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Germany
Project Manager

Project Manager

Germany

Job Summary

The Project Manager is responsible for the day-to-day management of client projects and ensures that projects are delivered on time, within budget and according to client expectations.

This position is office-based in Munich, Germany.

Responsibilities

  • Provide leadership in the delivery of services to clients, reviews work produced by the project teams, and ensures that staff fulfills their responsibilities in accordance with project contracts and MedAvante policies, procedures and SOPs.
  • Possess the ability to provide practical solutions to problems and situations ordinarily encountered.
  • Experience in strategic analysis, developing project plans, budgeting, scheduling, risk management, resource allocation, and scope management.
  • Manage the project implementation with highest customer satisfaction.
  • Assist in the supervision and training of new and adjunct staff.
  • Build relationships with customer contacts.
  • Lead kickoff, design, status, and other project related meetings with cross-functional teams and project stakeholders at all levels.
  • Present study services at client meetings, such as at Study Monitor Meetings, Investigator Meetings, and project initiation (kick-off) meetings.
  • Train investigative sites on study procedures.
  • Develop complex project schedules, and manage project cost, scope, schedule and quality, as well as profitability.
  • Experience in leading and managing internal project teams and experience coordinating and managing multiple project efforts simultaneously.
  • Lead project discussions, including post-mortems and project checkpoints.
  • Closely manage the entire project life cycle. Identify and track issues, risks, dependencies, efficiencies, and critical path objectives.  Escalate as necessary.
  • As part of project status tracking and reporting, continuously assess project risk factors and recommend appropriate courses of action to mitigate.
  • Provide timely and audience-specific status reports in support of defined metrics to the Senior Vice President, Global Operations and other key stakeholders.

Education / Qualifications:

  • Bachelor’s degree in related field and/or 3 to 5 years related experience in a clinical project management environment (e.g.CRO, pharmaceutical company, or other centralized service provider used in clinical studies) or the equivalent combination of education, skills and experience to perform the job.
  • PMP Certification preferred.
  • Experience with clinical trials in CNS, Alzheimer’s/Dementia preferred.
  • Minimum of 1 year supervisory experience recommended.
  • Knowledge of project management software tools and management techniques.

Experience / Skills

  • Possess demonstrated experience in developing complete project plans and executing the management and implementation of those plans on time and within budget.
  • Must have first-hand experience with all stages of the project life-cycle, from requirements gathering to completion of project.
  • Ability to function effectively in a fast paced environment and manage multiple projects simultaneously.
  • Demonstrated leadership skills and ability to manage, motivate, and integrate a team.
  • Excellent problem solving/decision making skills.
  • Proven project management experience.
  • Outstanding written and oral communication skills.
  • Excellent organizational skills.
  • Demonstrated negotiation skills.
  • Excellent interpersonal skills. Ability to lead through influencing and negotiating.
  • Strong facilitation and coordination skills.
  • Ability to multi-process, delegate project tasks.
  • Demonstrated understanding and compliance with MedAvante Employee Manual.
  • Proficient knowledge of MS Office, specifically Word, Excel, Access and PowerPoint as well as Adobe, Visio and MS Project and the ability to produce detailed reports and presentations using these tools.

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Hamilton, NJ
Project Coordinator, Scale Management

Project Coordinator, Scale Management

Hamilton, NJ

 Job Summary

The Project Coordinator, Scale Management provides support for projects according to MedAvante SOPs and GCP. The successful incumbent provides quality customer service and assists in ensuring that projects are delivered on time and according to client expectations.   

Responsibilities

  • Provide administrative support for Scale Management Department:
  • Applying knowledge of linguistic validation/translation methodology and licensing requirements, provide project support and serve as a department interface with internal departments including Project Management, Clinical Trial Services, IT-Development and Regulatory/QA (10%).
  • Provide support with regard to third party vendors including responding to queries, assisting with problem resolution and processing of contracts for signature (10%).
  • Provide timely status reports to internal and external stakeholders (5%).
  • Assist with project implementation with a focus on service delivery of the highest level.
  • Using a variety of tools, facilitate the processing of scales, forms and documents requiring linguistic validation or translation (30%).
  • Update, track, and maintain scale/form management tools and systems (internal and external) (10%).
  • Set-up and maintain files for storage of documents (i.e., license agreements, vendor contracts, translated scales and forms) (10%).
  • Assist with research on scale licensing requirements (10%).
  • Review, reconcile and process third party vendor invoices (5%).
  • Maintain tracking in order to ensure that MedAvante, on behalf of its sponsors, fulfills license agreement obligations (5%).
  • Attend department status meetings and teleconferences with vendors and internal study team members.  Record and distribute minutes as needed (5%).
  • Recommends solutions to streamline the efficiencies of internal department processes.

Education / Qualifications:

  • University/college degree (life science preferred) or the equivalent combination of education, skills and experience to perform the job.
  • Minimum 1 year related experience and/or training in a clinical trial or research environment.
  • 1 – 2 years’ experience working with licensing and linguistic validation/translation of clinical outcome assessments (COAs) preferred.
  • Basic understanding of GCP.

Experience / Skills:

  • Ability to work in a fast-paced environment and support multiple projects concurrently.
  • Ability to work within a project team.
  • Good planning, organization and problem solving abilities.
  • Strong communication skills, oral and written.
  • Proficient in MS Office, specifically Word, Excel and Outlook.
  • Detail oriented.
  • Upholds organizational values.
  • Able to work flexible hours to provide support on a global basis as needed.
  • Fluent in English, bi-lingual or multi-lingual skills preferred.

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Hamilton, NJ
Customer Support Specialist I

Customer Support Specialist I

Hamilton, NJ

Job Summary

 

The Customer Support Specialist I provides Tier 1 level support to external MedAvante customers.

Responsibilities

  • Answer inbound calls and e-mails, determine customer problems through asking appropriate questions, and help customers resolve issues.
  • Investigate, resolve and escalate issues to the appropriate internal team member.
  • Log calls and resolutions through our Salesforce database system.
  • Train and stay current on all present and future internal systems and devices.
  • Work in a team environment supporting a 24 x 5 call center.
  • Possess general understanding of the company Systems and Methodology.
  • Occasional flexibility in work hours may be required in order to cover for vacations, training sessions and other similar company activities.
  • Assist in daily operations including, but not limited to, telephone and email support, diagnosing problems and completing regularly scheduled activities.
  • May be required to schedule and/or initiate clinical assessments.
  • May be required to enter clinical assessment data points into one or more systems.
  • Other duties as assigned by Management

 

Education / Qualifications:

 

  • Bachelor’s or Associate’s degree preferred or equivalent professional experience.
  • 1 + years’ experience providing technical trouble-shooting support over the telephone and via e-mail or 1 + years’ Clinical trial experience with direct site/sponsor contact.

 

Experience / Skills
 

  • Strong customer service and clear and concise verbal communication skills, especially over the telephone.  This includes the ability to ask questions to quickly and accurately understand customer issues as well as the ability to communicate/translate technical concepts and instructions to non-technical customers.
  • Demonstrated technical problem solving capabilities.
  • Excellent written and verbal skills are necessary to effectively convey directions and information to both external customers and internal team members.
  • Ability to successfully handle and prioritize multiple work requests and/or projects simultaneously with little or no immediate supervision.
  • Possess strong analytical and problem solving skills.
  • Possess good interpersonal skills and attention to customer service.
  • Ability to learn new technical skills and processes quickly.
  • Proficient in Microsoft office.

 

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Hamilton, NJ
Manager, Proposals

Manager, Proposals

Hamilton, NJ

Job Summary

The Manager, Proposals will collaborate with the Business Development team in the winning of business to achieve agreed sales targets.   Responsible for preparing high quality customer focused domestic and global proposals.   This responsibility includes preparing the text for proposals, project budgets, change orders, RFI’s, RFP’s, re-bids, and related documents for VP’s approval.  Manages proposal development process, sources proposal content from Operations, Project Management, Business Development and Sr. Management and ensures consistency, quality and timeliness of proposal submissions.

Responsibilities

  • Responsible for preparation, review and finalization of domestic and global proposals/budgets.  Participates as a part of the dedicated team to ensure consistency in approach, metrics and format.
  • Participates in resource calls with clients to support proposal development and negotiations activities.  Must be able to identify discrepancies in client information.
  • Communicates customer requirements to MedAvante internal stakeholders such as Operations, Project Management and Finance and solicits input from stakeholders for proposal generation.
  • Works closely with Operations to develop cost estimates for new services and modifications to existing services
  • Conduct proposal status meetings.
  • Prepares proposal text, customizing all documents to accurately reflect services to be provided.  Oversees the finalization of documents and distributions to internal departments for final review and official submission to customer.
  • Develops and maintains working relationships with customer contacts and responds to customer specific requirements as related to proposal and change order requests.
  • Follow up with clients after the submission of proposals as needed.  Conduct verbal and/or written follow up with clients for change order requests.
  • Updates and maintains corporate customer database (CRM) as required and develop RFx document library.
  • Ensures accurate information is included in tracking reports (specifically CRM).
  • Performs quality control edits on all documents.
  • Create, review, maintain and revise as required, proposal templates and procedural documents.
  • Drive consistency, efficiency and identification of best practices in the development of proposals.
  • Participates in the development of department procedures and processes.
  • Available for travel to channel partners such as CRO vendors.
  • Performs all other duties as assigned in the business development and sales communication area.

Education / Qualifications:

  • Bachelor's Degree in Life Science (primary consideration), business management, or other related field (secondary) preferred.
  • CRO experience/services-based companies preferred.
  • A minimum of 5 years direct experience in proposal development, working with and managing proposal activities or 5 years, sales management/business development, or other comparable combination of education, training and experience.

Experience / Skills

  • Possess strong organizational skills and attention to detail.
  • Possess strong listening, analytical, written and verbal communication skills.
  • Possess strong interpersonal skills (professional, customer service driven) with the ability to manage multiple projects and team members involved in proposal generation activities.
  • Ability to prepare and interpret budgets.  Strong math skills.
  • Ability to learn and use current Excel based pricing models as well as develop new pricing models.
  • Demonstrated working knowledge of Word and windows based e-mail systems preferred.
  • Advanced Excel skills (must be comfortable creating and interpreting formulas, vlook-ups).
  • Experience working with operations to develop change orders.
  • Ability to manage changing priorities.
  • Experience with SalesForce.com desirable.
  • Must possess superior, professional writing and editing skills.
  • Excellent follow-through skills and the willingness to take ownership of assignments.
  • Ability to coordinate activities focused on the preparation, production and publication of sensitive documents.
  • Willingness to work extended hours.
  • Knowledge of drug development/pharmaceutical industry a plus.


 

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U.S. - Any Location
Clinical Scientist

Clinical Scientist

U.S. - Any Location

Job Summary

The Clinical Scientist supports projects from a clinical perspective across therapeutic areas in conjunction with project management. Additionally, the Clinical Scientist is responsible for site rater training and the training and calibration of the MedAvante clinicians.  This individual will have experience conducting assessments in CNS clinical trials as well as interacting with investigative sites and study sponsors.

Responsibilities:

  • External facing clinical representative responsible for the independent clinical management of large, international clinical trials.
  • Liaise with sponsors and sites.
  • Resolve assessment results inquiries raised by sites by working with Project Managers, and Director of Clinical Trial Services as necessary.
  • Interact with sponsors on rater qualifications/CV review.
  • Attend internal and external project meetings (e.g., weekly external client call, Investigators’ Meetings). 
  • Review and monitor study level metrics; present study dashboards to sponsors as necessary.
  • Determine and inform appropriate Clinical Trial Services staff of study requirements (resource and training needs) while managing project specific rater resource requirements based upon projections.
  • Ensure clinical quality standards are met by monitoring internal clinician and team level performance across studies and scales and resolve clinical quality or training related issues, as directed by the Director, Clinical Trial Services.
  • Ensure calibration of clinical team members and conduct rater training events as specified in Training plans.
  • Provide clinical consultation to MedAvante Clinicians and site raters
  • Participate in the process of adding and removing clinicians from a study and ensuring they are assigned within designated timeframes.
  • Work with the Director, Clinical Trial Services to develop and revise Training plans as needed.
  • Communicate with other departments (e.g., Project Management) to meet project   objectives. Coordinate resources and develop materials for Investigator Meetings.
  • Assist with or responsible for the development of project deliverables (e.g., scale verification, electronic form development, training materials for in-person or online training, etc.)
  • Work with Business Development to review potential studies, RFPs, etc.
  • Work with Marketing to support site initiatives.
  • Develop and oversee implementation of external site rater training.
  • Maintain calibration on relevant clinical scales.
  • Identify the need for and develop as needed work instructions, process guidelines and standard operating procedures and ensure processes and procedures meet SOP/GCP requirements.
  • Manage various project specific budget tasks/activities.
  • May require domestic and international travel.
  • Perform other job duties as determined by management.

Education / Qualifications:

  • Graduate degree in psychology, social work, counseling, psychiatric nursing or related field.
  • Minimum 4 years’ experience administering psychiatric symptom rating scales and/or Neurocognition scales, experience with structured diagnostic interviews preferred.
  • Minimum 3 years’ experience in a clinical trial or research setting or other clinical setting preferred.
  • Fluent in English, bi-lingual or multi-lingual skills are preferred.
  • Basic understanding of GCP.
  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Ability to travel as required.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Experience / Skills
 

  • Ability to function effectively in a fast paced environment and manage multiple projects simultaneously.
  • Demonstrate leadership skills
  • Strong problem solving/decision making skills.
  • Proven project management experience at an intermediate level.
  • Solid understanding of basic and intermediate statistics.
  • Strong written and oral communication skills.
  • Strong interpersonal and organizational skills.
  • Demonstrate negotiation skills.
  • Ability to lead through influencing and negotiating.
  • Strong facilitation and coordination skills.
  • Ability to multi-process, delegate project tasks.
  • Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and the ability to produce detailed reports and presentations using these tools.

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Germany
Senior Project Manager (Clinical)

Senior Project Manager (Clinical)

Germany

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. Our Project Managers handle the dynamic requirements of planning, launching and managing client projects on a global scale. If you are a project management professional with the skills to deliver on time, within budget and exceeding client expectations, and experience leading project teams, coordinating and managing multiple project efforts simultaneously, you will want to consider joining the MedAvante team.

This position is office based in Munich.

Responsibilities:

  • Provide leadership in the delivery of services to clients.
  • Review work produced by the project teams, and ensures that staff fulfills their responsibilities in accordance with project contracts and MedAvante policies, procedures and SOPs.
  • Develop and implement practical solutions to a broad array of challenges and situations.
  • Experience in strategic analysis, developing project plans, budgeting, scheduling, risk management, resource allocation, and scope management.
  • Supervise, train and mentor junior and adjunct staff.
  • Build long term relationships with all levels of customer contacts.
  • Lead kickoff, design, status, and other project related meetings with cross-functional teams and project stakeholders at all levels.
  • Present study services at client meetings, such as at Study Monitor Meetings, Investigator Meetings, and project kick-off meetings.
  • Train investigative sites on study procedures.
  • Develop complex project schedules, and manage project cost, scope, schedule and quality.
  • Lead project discussions including post-mortems and project checkpoints.
  • Closely manage the entire project life cycle. Identify and track issues, risks, dependencies, efficiencies, and critical path objectives.
  • Continuously assess project risk factors and recommend appropriate courses of action to mitigate.
  • Support business development activities by assisting in the proposal development process (e.g., provide costing and proposal text focused upon study specifications).
  • Participate in client presentations for new business.
  • Provide timely and audience-specific status reports in support of defined metrics.

Education / Qualifications:

  • Bachelor’s degree in related field and/or 3 to 5 years related experience and/or training in a clinical project management environment (e.g., CRO, pharmaceutical company, or other centralized service provider used in clinical studies) or the equivalent combination of education, skills and experience to perform the job.
  • Minimum of 3 years supervisory experience recommended.
  • Knowledge of project management software tools and management techniques.

Experience / Skills:

  • Possess demonstrated experience in developing complete project plans and executing the management and implementation of those plans on time and within budget.
  • Must have first hand experience with all stages of the project life-cycle, from requirements gathering to release.
  • Ability to function effectively in a fast paced environment and manage multiple projects simultaneously.
  • Demonstrate leadership skills and ability to manage, motivate, and integrate a team.
  • Excellent problem solving/decision making skills.
  • Proven project management experience at senior level.
  • Outstanding written and oral communication skills.
  • Excellent organizational skills.
  • Demonstrate negotiation skills.
  • Excellent interpersonal skills. Ability to lead through influencing and negotiating.
  • Strong facilitation and coordination skills.
  • Ability to multi-process, delegate project tasks.
  • Demonstrate understanding and compliance with MedAvante Employee Manual.
  • Proficient knowledge of MS Office, specifically Word, Excel, Access and PowerPoint as well as Adobe, Visio and MS Project and the ability to produce detailed reports and presentations using these tools.
  • Possess a valid driver’s license.

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Remote Office
Clinician - Arabic speaker (for Central Review) - On-Demand

Clinician - Arabic speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Principal Clinician – Central Review evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Provide scoring for site assessments and review site scores.
  • Review site assessments for quality assurance.
  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May assume primary responsibility for major research and other projects.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with neurocognition disorders.
  • Minimum of 2 years administering standardized assessment tools (MMSE, ADAS-Cog, CDR, ADCS-ADLI, RBANS)

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Arabic native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician - Afrikaans speaker (for Central Review) - On-Demand

Clinician - Afrikaans speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Principal Clinician – Central Review evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Provide scoring for site assessments and review site scores.
  • Review site assessments for quality assurance.
  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May assume primary responsibility for major research and other projects.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with neurocognition disorders.
  • Minimum of 2 years administering standardized assessment tools (MMSE, ADAS-Cog, CDR, ADCS-ADLI, RBANS)

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Afrikaans native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician - Ukrainian / Russian speaker (for Central Review) - On-Demand

Clinician - Ukrainian / Russian speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Principal Clinician – Central Review evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Provide scoring for site assessments and review site scores.
  • Review site assessments for quality assurance.
  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May assume primary responsibility for major research and other projects.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with neurocognition disorders.
  • Minimum of 2 years administering standardized assessment tools (MMSE, ADAS-Cog, CDR, ADCS-ADLI, RBANS)

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Ukrainian and Russian native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician - Greek speaker (for Central Review) - On-Demand

Clinician - Greek speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Principal Clinician – Central Review evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Provide scoring for site assessments and review site scores.
  • Review site assessments for quality assurance.
  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May assume primary responsibility for major research and other projects.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with neurocognition disorders.
  • Minimum of 2 years administering standardized assessment tools (MMSE, ADAS-Cog, CDR, ADCS-ADLI, RBANS)

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Greek native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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U.S. - Any Location
Solutions Engineer

Solutions Engineer

U.S. - Any Location

Job Summary

As a member of the Business Development (BD) group, the Solutions Engineer will report to the Client Services lead, providing product/domain expertise to Patient-Reported Outcome (PRO) components of the MedAvante Virgil platform, based on experience with and end-to-end knowledge of PRO-related processes and electronic support (ePRO).  He/she will provide guidance and support for all operational aspects of ePRO implementation, including participating in client dialogues and meetings, preparing ePRO-related input to bids and proposals, and supporting the VP, Patient-Centric Outcomes in addressing product development questions and formulating go-to-market analysis.

Responsibilities

  • Serve as ePRO subject matter expert on the Client Services team.
  • Work with BD and other colleagues to prepare client engagement materials (e.g., capabilities presentations, proposals, bid defenses) and participate with BD Directors in client dialogues, product demonstrations and other meetings.
  • Interact with VP, Patient-Centric Outcomes on clinical science issues and go-to-market questions.
  • Provide input into ePRO-related product development.
  • Participate in customer needs analysis discussions.
  • Represent MedAvante at conferences and other events, including trade show booth staffing.
  • Work with clients to define optimal implementation of patient-centric clinical outcome measurements.
  • Play contributory role in sales meetings, strategic account planning and prospect follow-up activities.
  • Train internal MedAvante staff on new features and enhancements, including internal workshops for staff as needed.

Education / Qualifications:

  • Advanced degree (MBA, Ph.D) preferred
  • 7+ years of ePRO provision for clinical studies (considered a subject matter expert) with hands-on operational experience.
  • 3 + years of experience in a solutions engineer role. (Preferred)
  • Extensive knowledge of current ePRO marketplace, including vendor strengths/weaknesses and service offerings.
  • Knowledge of regulatory guidelines in clinical trials
  • Excellent at presenting PRO-based information to internal/external audiences.
  • Solid analytical and technical skills.
  • Self-motivating, able to assume responsibility and work autonomously in a professional manner.
  • Must be comfortable working with and, as needed, managing external vendors.
  • Strong oral and written communication skills are essential.
  • Comfortable with travel both domestic and internationally.

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Hamilton, NJ
Senior Project Manager (Clinical)

Senior Project Manager (Clinical)

Hamilton, NJ

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. Our Project Managers handle the dynamic requirements of planning, launching and managing client projects on a global scale. If you are a project management professional with the skills to deliver on time, within budget and exceeding client expectations, and experience leading project teams, coordinating and managing multiple project efforts simultaneously, you will want to consider joining the MedAvante team.

Responsibilities:

  • Provide leadership in the delivery of services to clients.
  • Review work produced by the project teams, and ensures that staff fulfills their responsibilities in accordance with project contracts and MedAvante policies, procedures and SOPs.
  • Develop and implement practical solutions to a broad array of challenges and situations.
  • Experience in strategic analysis, developing project plans, budgeting, scheduling, risk management, resource allocation, and scope management.
  • Supervise, train and mentor junior and adjunct staff.
  • Build long term relationships with all levels of customer contacts.
  • Lead kickoff, design, status, and other project related meetings with cross-functional teams and project stakeholders at all levels.
  • Present study services at client meetings, such as at Study Monitor Meetings, Investigator Meetings, and project kick-off meetings.
  • Train investigative sites on study procedures.
  • Develop complex project schedules, and manage project cost, scope, schedule and quality.
  • Lead project discussions including post-mortems and project checkpoints.
  • Closely manage the entire project life cycle. Identify and track issues, risks, dependencies, efficiencies, and critical path objectives.
  • Continuously assess project risk factors and recommend appropriate courses of action to mitigate.
  • Support business development activities by assisting in the proposal development process (e.g., provide costing and proposal text focused upon study specifications).
  • Participate in client presentations for new business.
  • Provide timely and audience-specific status reports in support of defined metrics.

Education / Qualifications:

  • Bachelor’s degree in related field and/or 3 to 5 years related experience and/or training in a clinical project management environment (e.g., CRO, pharmaceutical company, or other centralized service provider used in clinical studies) or the equivalent combination of education, skills and experience to perform the job.
  • Minimum of 3 years supervisory experience recommended.
  • Knowledge of project management software tools and management techniques.

Experience / Skills:

  • Possess demonstrated experience in developing complete project plans and executing the management and implementation of those plans on time and within budget.
  • Must have first hand experience with all stages of the project life-cycle, from requirements gathering to release.
  • Ability to function effectively in a fast paced environment and manage multiple projects simultaneously.
  • Demonstrate leadership skills and ability to manage, motivate, and integrate a team.
  • Excellent problem solving/decision making skills.
  • Proven project management experience at senior level.
  • Outstanding written and oral communication skills.
  • Excellent organizational skills.
  • Demonstrate negotiation skills.
  • Excellent interpersonal skills. Ability to lead through influencing and negotiating.
  • Strong facilitation and coordination skills.
  • Ability to multi-process, delegate project tasks.
  • Demonstrate understanding and compliance with MedAvante Employee Manual.
  • Proficient knowledge of MS Office, specifically Word, Excel, Access and PowerPoint as well as Adobe, Visio and MS Project and the ability to produce detailed reports and presentations using these tools.
  • Possess a valid driver’s license.

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Remote Office
Clinician - Bulgarian speaker (for Central Review) - On-Demand

Clinician - Bulgarian speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Principal Clinician – Central Review evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Provide scoring for site assessments and review site scores.
  • Review site assessments for quality assurance.
  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May assume primary responsibility for major research and other projects.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with neurocognition disorders.
  • Minimum of 2 years administering standardized assessment tools (MMSE, ADAS-Cog, CDR, ADCS-ADLI)

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Bulgarian native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician - Bulgarian speaker (for Central Review) - On-Demand

Clinician - Bulgarian speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Principal Clinician – Central Review evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

 

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • Conduct trainings for site raters.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician calibration and training.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with psychiatric disorders
  • Familiar with administering the PANSS scale
  • Ability to conduct reviews of rater severity and/or diagnostic sessions, providing feedback for quality control purposes.

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Bulgarian native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician (home-based, on-demand) for Singapore

Clinician (home-based, on-demand) for Singapore

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Clinician evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

This position is home-based (any location).

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Associates to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • May participate in Clinical and Team meetings.
  • Participate in on-going Clinician scoring exercises and training.
  • May participate in staff meetings.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Minimum of a Master’s degree conferred by a clinically-focused program in a mental health discipline such as Psychology, Social Work, Counseling or Psychiatric Nursing.
  • Minimum of 2 years clinical experience diagnosing and/or treating patients with psychiatric disorder, neurocognition disorders and/or other study relevant indications.
  • 2 or more years administering study relevant standardized assessment tools and/or 2 years of working as a MedAvante clinician.

  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • Proficient in Malay and English as spoken in Singapore.
  • Ability to work collaboratively within the company.

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Hamilton, NJ
Customer Support Specialist II

Customer Support Specialist II

Hamilton, NJ

Job Summary

 

The Customer Support Specialist II provides Tier I level support to external MedAvante customers.  May provide assistance or train less experienced support specialists on the handling of complicated issues.

Responsibilities

  • Lead and support Customer Support Specialists.
  • Train new hires on help desk policies and procedures.
  • Answer inbound calls and e-mails, determine customer problems through asking appropriate questions, and help customers resolve issues.
  • Investigate, resolve and escalate issues to the appropriate internal team members.
  • Log calls and resolutions through Salesforce database system.
  • Train and stay current on all present and future internal systems and devices.
  • Assist with defining policies and procedures to improve call handling and resolution process.
  • Work in a team environment supporting a 24x5 call center.
  • Possess general understanding of the company Systems and Methodology. 
  • Assist Management with requested reports and other activities that may be requested.
  • Assist with creating/updating SOPs and Work Instructions as needed.
  • Occasional flexibility in work hours may be required in order to cover vacations, training sessions and other similar company activities.
  • Assist in daily operations including, but not limited to, telephone and email support, diagnosing problems and completing regularly scheduled activities.
  • May be required to schedule and/or initiate clinical assessments.
  • May be required to enter clinical assessment data points into one or more systems.

 

Note:  Other duties may be assigned by Management

 

Education / Qualifications:

 

  • Bachelor’s degree preferred or equivalent professional experience. 
  • 3 + years’ experience providing technical trouble-shooting support over the telephone and via e-mail or 3 + years’ Clinical trial experience with direct site/sponsor contact.

 

Experience / Skills
 

  • Strong customer service and clear and concise verbal communication skills, especially over the telephone.  This includes the ability to ask questions to quickly and accurately understand customer issues as well as the ability to communicate/translate technical concepts and instructions to non-technical customers.
  • Demonstrated technical problem solving capabilities.
  • Excellent written and verbal skills are necessary to effectively convey directions and information to both external customers and internal team members.
  • Ability to successfully handle and prioritize multiple work requests and/or projects simultaneously with little or no immediate supervision.
  • Ability to learn new technical skills and processes quickly.
  • Ability to work under pressure.
  • Must possess good leadership qualities to inspire people to reach their full potential.
  • Must be knowledgeable about service desk system and IT tools.
  • Possess strong analytical and problem solving skills.
  • Possess good interpersonal skills and attention to customer service.
  • Proficient in Microsoft Office.

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Hamilton, NJ
Clinical Specialist, eForm Development

Clinical Specialist, eForm Development

Hamilton, NJ

Job Summary

The Clinical Specialist in eForm Development supports development of Virgil eForms from a clinical perspective across therapeutic areas in conjunction with IT Development. The Clinical Specialist will be responsible for ensuring timely completion of Virgil eForms while adhering to quality standards and clinical validity. This individual will have experience conducting assessments in clinical trials as well as interacting with investigative sites and study sponsors. The incumbent will assist in ensuring the organization’s operational efficacy and excellence by working with the different operational units in translating groups’ business requirements to particular software requirements and/or procedural workflows.

Responsibilities

  • Provide clinical subject matter expertise in the development of Virgil eForms to meet the client’s business needs.
  • Communicate and coordinate effectively with internal teams to deliver requirements for electronic form layout, interface and validation rules/edit checks.
  • Provide support to the Business Analyst and Test teams through Clinical validation expertise to test, validate and evaluate work completed by the eForms team.
  • Participate in team meetings and communicate regularly with remote staff and other employees.
  • Review and evaluate data collected through Virgil, Central Ratings, Central Review, internal usability testing, surveys, and marketing research to improve functionality and clinical guidance included in eForms.
  • Liaise with sponsors and scale authors, as needed.
  • External facing clinical representative responsible for presenting eForm batteries utilized in large, international clinical trials, to sponsors for approval/adoption.
  • Work with the operational groups who test, validate and evaluate new applications and functions, and determine clinical related issues in services and software.
  • Identify the need for and develop as needed work instructions, process guidelines and standard operating procedures and ensure processes and procedures meet SOP/GCP requirements related to eForm development.
  • Evaluate a patient’s current clinical condition and symptom severity as needed and MedAvante qualified.
  • Perform diagnostic assessments as needed and MedAvante qualified.
  • May also review, score, and provide feedback to site raters regarding the administration of standardized structured and semi-structured diagnostic and severity assessments as needed and MedAvante Qualified.
  • Conduct trainings for site raters as needed and MedAvante qualified.
  • Perform other job duties as assigned by management.

 

Education / Qualifications:

  • Graduate degree in psychology, social work, counseling, psychiatric nursing or related field.
  • Minimum 4 years’ experience administering standardized assessment tools, psychiatric symptom rating scales and/or Neurocognition scales, experience with structured diagnostic interviews preferred.
  • Minimum 2 years’ experience in a clinical trial or research setting or other clinical setting is highly preferred.
  • Knowledge of clinical assessment best practices.
  • Fluent in English, bi-lingual or multi-lingual skills are preferred.
  • Basic understanding of GCP.

 

 

Experience / Skills:

 

  • Ability to function effectively in a fast paced environment and manage multiple projects simultaneously.
  • Demonstrate leadership skills and ability to manage, motivate, and integrate a team.
  • Strong problem solving/decision making skills.
  • Effective project management skills.
  • Ability to think analytically and adept at problem solving.
  • Solid understanding of basic and intermediate statistics.
  • Strong written and oral communication skills.
  • Strong interpersonal and organizational skills.
  • Demonstrate negotiation skills.
  • Ability to lead through influencing and negotiating.
  • Strong facilitation and coordination skills.
  • Ability to multi-process, delegate project tasks.
  • Advanced skills in MS Word, Excel, and Adobe.

 


 

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Hamilton, NJ
Project Manager

Project Manager

Hamilton, NJ

Job Summary:

The Project Manager is responsible for the day-to-day management of client projects and ensures that projects are delivered on time, within budget and according to client expectations.

 

Responsibilities:

  • Provide leadership in the delivery of services to clients, reviews work produced by the project teams, and ensures that staff fulfills their responsibilities in accordance with project contracts and MedAvante policies, procedures and SOPs.
  • Possess the ability to provide practical solutions to problems and situations ordinarily encountered.
  • Experience in strategic analysis, developing project plans, budgeting, scheduling, risk management, resource allocation, and scope management.
  • Manage the project implementation with highest customer satisfaction.
  • Assist in the supervision and training of new and adjunct staff.
  • Build relationships with customer contacts.
  • Lead kickoff, design, status, and other project related meetings with cross-functional teams and project stakeholders at all levels.
  • Present study services at client meetings, such as at Study Monitor Meetings, Investigator Meetings, and project initiation (kick-off) meetings.
  • Train investigative sites on study procedures.
  • Develop complex project schedules, and manage project cost, scope, schedule and quality, as well as profitability.
  • Experience in leading and managing internal project teams and experience coordinating and managing multiple project efforts simultaneously.
  • Lead project discussions, including post-mortems and project checkpoints.
  • Closely manage the entire project life cycle. Identify and track issues, risks, dependencies, efficiencies, and critical path objectives.  Escalate as necessary.
  • As part of project status tracking and reporting, continuously assess project risk factors and recommend appropriate courses of action to mitigate.
  • Provide timely and audience-specific status reports in support of defined metrics to the Senior Vice President, Global Operations and other key stakeholders.
  • Perform other job duties as determined by the Associate Director, Project Management or senior management.

 

Education / Qualifications:

  • Bachelor’s degree in related field and/or 3 to 5 years related experience in a clinical project management environment (e.g.CRO, pharmaceutical company, or other centralized service provider used in clinical studies) or the equivalent combination of education, skills and experience to perform the job.
  • PMP Certification preferred.
  • Experience with clinical trials in CNS, Alzheimer’s/Dementia preferred.
  • Minimum of 1 year supervisory experience recommended.
  • Knowledge of project management software tools and management techniques.

 

Experience / Skills:

  • Possess demonstrated experience in developing complete project plans and executing the management and implementation of those plans on time and within budget.
  • Must have first-hand experience with all stages of the project life-cycle, from requirements gathering to completion of project.
  • Ability to function effectively in a fast paced environment and manage multiple projects simultaneously.
  • Demonstrated leadership skills and ability to manage, motivate, and integrate a team.
  • Excellent problem solving/decision making skills.
  • Proven project management experience.
  • Outstanding written and oral communication skills.
  • Excellent organizational skills.
  • Demonstrated negotiation skills.
  • Excellent interpersonal skills. Ability to lead through influencing and negotiating.
  • Strong facilitation and coordination skills.
  • Ability to multi-process, delegate project tasks.
  • Demonstrated understanding and compliance with MedAvante Employee Manual.
  • Proficient knowledge of MS Office, specifically Word, Excel, Access and PowerPoint as well as Adobe, Visio and MS Project and the ability to produce detailed reports and presentations using these tools.
  • Possess a valid driver’s license and passport.


 

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Hamilton, NJ
Alliance Management

Alliance Management

Hamilton, NJ

Job Summary

The incumbent is responsible for establishing or enhancing business relationships and partnerships between MedAvante and other key stakeholders in clinical trials. Activities will be targeted towards increasing the request-for-proposal (RFP) volume MedAvante receives via alliance partners, enhancing the competitive differentiation and adoption of our solutions in the market space and improving the efficiency of our products via interoperability with other technology platforms. Potential partnerships include CROs, technology providers for clinical trials, site management organizations, key opinion leaders (KOLs) and other stakeholders. Incumbent will be a member of the Business Development team and will be collaborating with other departments such as Product Management, IT and the Executive Team.

Responsibilities

  • Establish relationships with other trial stakeholders such as CROs to create new business opportunities and sales channels for MedAvante.
  • Develop the commercial concept and components of partnering agreements.
  • Manage established partnering contacts on the daily level and facilitate C-level dialogue.
  • Analyze trends in the clinical trial industry (risk-based monitoring, data analytics, site networks, sensor devices) for potential partnering opportunities.
  • Collaborate with Business Development Team on closing business.
  • Present MedAvante capabilities to potential partners (e.g. CRO proposal teams).
  • Perform networking activities at conferences and special interest group meetings.
  • Ability and willingness to travel (domestically and internationally), estimated 20%.

Education / Qualifications:

  • BS/BA degree.  Master’s preferred.
  • Seven (7) plus years’ of industry experience, either from working at a clinical service company (CRO) or e-clinical technology company (e.g. EDC vendor) in an alliance management, corporate development or business development role.
  • Experience in and in-depth knowledge of clinical trial services (e.g. traditional monitoring, risk-based monitoring, data analytics).
  • Five (5) years’ experience in a leadership position.
  • Experience developing and executing partnering go-to-market plans.
  • Team player with strong drive and willing to take a leadership role in driving initiatives, working effectively across the organization and creating unique approaches to developing new revenue opportunities.   

Experience / Skills

  • Proven success building strategic business and alliance plans.
  • Strong knowledge of the CRO and clinical trial service industry.
  • Strong business and analytic acumen.
  • Strategic thinker who is capable of blending technical and business strategy to develop compelling partnering initiatives.
  • Demonstrated networking, persuasion and presentation skills.
  • Ability to simplify complex concepts and make them relatable to potential partners.
  • Ability to adjust to new, different or changing requirements.
  • Strong written and verbal communication skills.
  • Demonstrates different influence styles as appropriate to situation while maintaining positive relationships.
  • Proficiency in Microsoft Office Suite.

 

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Remote Office
Clinician / Neurologist - French speaker (for Central Review) - On-Demand

Clinician / Neurologist - French speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Clinician evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Coordinators to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • Participate in on-going Clinician scoring exercises and training.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Clinicians must have a qualification as a Medical Doctor with a specialization in the field of Neurology.
  • Minimum 2 years’ clinical experience diagnosing and/or treating patients with psychiatric disorders, neurocognition disorders, and/or other study relevant indications.
  • 2 or more years administering study relevant standardized assessment tools, including a minimum of 2 years experience administering movement disorder scales (MDS UPDRS , etc.).
  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • French native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Remote Office
Clinician / Neurologist - German speaker (for Central Review) - On-Demand

Clinician / Neurologist - German speaker (for Central Review) - On-Demand

Remote Office

Job Summary

MedAvante is the clinical data sciences company that is revolutionizing drug development with smarter, faster clinical trials. The Clinician evaluates the administration of standardized structured and semi-structured diagnostic and severity assessments and provides constructive feedback to the clinicians at clinical trial sites who conduct these assessments. If you want to be part of a clinical team dedicated to unlocking new, more effective treatments and enhancing the lives of patients and those who care for them, this is an opportunity you should investigate.

Responsibilities

  • Submit accurate review of site data utilizing standardized conventions.
  • Utilize technology required to review and score site assessments.
  • Work with MedAvante Project Coordinators to schedule assessment reviews, submit appropriate review documentation and provide data clarification.
  • Follow Sponsor (protocol-specific) requirements and applicable Good Clinical Practices and MedAvante internal SOPs.
  • Participate in on-going Clinician scoring exercises and training.
  • Responsible for keeping up to date with departmental and company communications to ensure one follows current policies, scale conventions, study procedures, and other pertinent information.

Job Requirements:

  • Clinicians must have a qualification as a Medical Doctor with a specialization in the field of Neurology.
  • Minimum 2 years’ clinical experience diagnosing and/or treating patients with psychiatric disorders, neurocognition disorders, and/or other study relevant indications.
  • 2 or more years administering study relevant standardized assessment tools, including a minimum of 2 years experience administering movement disorder scales (MDS UPDRS , etc.).
  • Proficiency with MS Word, Excel, Outlook and PowerPoint.
  • Knowledge of GCP guidelines.
  • Strong communication skills, oral and written.
  • German native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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Hamilton, NJ
Project Coordinator

Project Coordinator

Hamilton, NJ

Job Summary

The Project Coordinator provides support for projects according to MedAvante SOPs and GCP. The successful incumbent provides quality customer service and assists in assuring that projects are delivered on time and according to client expectations.   

Responsibilities

  • Interface and provide project support as a liaison between internal departments, e.g., Project Management, Clinical Trial Services and IT and the investigative research sites and Sponsor representatives.  Support may include set-up, training, follow-up on operational questions, data management and patient safety issues (including but not limited to written and verbal communication, provision of materials and other activities related to MedAvante projects).
  • Update, track, and maintain study-specific trial management tools / systems. Set-up and maintain study files (study specific, investigator, etc.)
  • Apply knowledge of internal systems to support MedAvante clinicians, investigative sites and project activities (this may include but is not limited to managing site rater training or assessment activities.
  • Provides external customer support by determining requirements, answering inquiries, research and explore issue resolutions and escalating as appropriate, and maintaining internal issue management application.
  • Attend project team meetings and teleconferences, as well as record and distribute meeting minutes, as needed. 
  • Assist with project implementation with highest customer satisfaction.
  • Train investigative sites on MedAvante study procedures as needed.
  • Assist in the development, preparation, and delivery of project documents, e.g., study specific addendums.
  • Provide timely status reports to internal and external key stakeholders.
  • Other duties assigned by management.

Education / Qualifications:

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or the equivalent combination of education, skills and experience to perform the job.
  • Minimum of 1 year related experience and/or training in a clinical services environment.
  • Experience working with psychiatric (e.g. depressions, anxiety) indications preferred.
  • Basic understanding of GCP.
  • Knowledge of IRB regulations and submissions (informed consent, etc.) preferred.
  • Must be proficient in native language of Hub Office and/or English.  
  • Experience / Skills
  • Ability to work in a fast-paced environment and support multiple projects concurrently and able to manage a variety of tasks.
  • Ability to work within a project team.
  • Good planning, organization and problem solving abilities.
  • Strong communication skills, oral and written.
  • Proficient in MS Office, specifically Word, Excel and Outlook.
  • Detail oriented.
  • Strong customer service skills.
  • Upholds organizational values.
  • Available for travel from 10% of the time, including overnight stays as necessary, consistent with project needs and office location.
  • Able to work flexible hours to provide support on a global basis as needed.
  • Experience with Salesforce a plus.
  • Multi-lingual a plus.

 

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Hamilton, NJ
Director, Business Development, ePro

Director, Business Development, ePro

Hamilton, NJ

Job Summary

As Director of Business Development, ePro you will be responsible for selling MedAvante’s specialized services to decision makers in pharmaceutical and biotech companies.  You will identify these decision makers and develop rapport with the objective of establishing long-term, mutually beneficial business partnerships.

Responsibilities

  • Sell MedAvante’s services to assigned potential and existing accounts.
  • Establish and has existing key contacts within the CNS pain and selected other therapeutic groups of the major pharmaceutical companies and/or biotech companies.
  • Act as the primary account management contact for selected key accounts.
  • Development and implementation of individual, territory and account strategies that incorporate significant account and industry profiling with pipeline, business development and retention strategies.
  • Contribute to market analysis on all key competitors including service offerings, acquisitions and pricing with a special focus on patient-reported outcomes vendors.
  • Contribute to proposal strategy, including pricing and service requirements.
  • Staying up-to-date with clinical trial design methodologies in the indication areas relevant to MedAvante..

Experience / Skills

Account Management Experience

  • 5-10 years of Account Management experience including experience in and in-depth knowledge of clinical trial design and drug development.
  • Sales experience in selling ePRO solutions (electronic patient-reported outcomes).
  • Experience in indication areas and clinical trials using clinical outcome measurements as endpoints (patient-reported outcomes, e.g. in pain clinical trials, respiratory, diabetes trials).
  • Track record of success in closed business metrics and quality of account relationships.

OR

Pharmaceutical Company Experience:

  • 5 or more years of experience in a pharmaceutical company, director level, from one of the following departments:
    • New Product Planning/CNS, Strategic Marketing/CNS, Global marketing
    • Involvement/input into CNS Phase II and Phase III clinical trials design/operations
    • Involvement in KOL identification and relationship building (ideally depression, schizophrenia, Alzheimer’s)
    • Previous sales experience required.
       
  • Experience interacting with senior members of pharmaceutical development organizations
  • Demonstration of the following competencies: results oriented, customer focus, excellent listening, communication, and negotiating skills, presentation skills, organization agility, business acumen, interpersonal savvy, ethics and values.

Education / Qualifications:

  • BS/BA degree
  • Advanced scientific degree strongly preferred
  • Familiar with Microsoft Outlook and Office
  • Must have or be eligible for a valid passport and driver’s license
  • Fundamental understanding of basic financial concepts

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