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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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Hamilton, NJ
Associate Data Manager

Associate Data Manager

Hamilton, NJ

Job Summary

Responsible for managing data management activities, including liaising with Sponsors, CRO’s and MedAvante QA on behalf of MedAvante Operations and Information Technology to ensure that project data requirements are communicated and met, project reporting needs required to monitor data quality are scheduled and delivered, data quality is monitored, and timelines and quality of data management deliverables are met according to project SLAs.

Responsibilities

  • Manage all aspects of data transfers to sponsors/CROs:
    1. Draft/Finalize Data Transfer Plans
    2. Create and test data extract files
    3. Create and provide sample/test data transfers to sponsors/CROs
    4. Perform data extract for periodic/routine data transfers
    5. Assist in resolving sponsor/CRO data queries
  • Manage Enterprise data (Sponsors, Investigators, Raters and Scales, etc.)
  1. Develop Data Conventions for entering, maintaining, cleaning enterprise data
  2. Train system users in data conventions
  • Manage Item Score repository:
  1. Work with Clinical Development to understand ways in which data will be analyzed
  2. Work with Operations to clean/complete data
  3. Work with IT development team to check/verify  continuous integration of enterprise and item score information from source databases
  • Implement solutions for handling process changes – through existing or new system features.
  • Develop (and/or write requirements for) data management reports/ queries to enable/facilitate data monitoring across all operational systems.
  • Run and review results of periodic/routine data checks.
  • Resolve/escalate production data issues by researching and identifying the root cause of the issue and working with appropriate resources to fix the issue.
  • Work with data owners (and QA) to document circumstances surrounding data discrepancies and solutions to address errors.
  • Detect and identify enhancements and improvements that increase the quality and efficiency of data processing.

 

Education / Qualifications:

  • BS/BA degree in related discipline or equivalent experience
  • Experience with electronic Clinical Database Systems is required and experience with electronic reporting applications preferred.
  • Knowledge of GCP is essential.
  • A minimum of 3 years of clinical data management experience is required in the bio/pharmaceutical or CRO industry.

 

Experience / Skills

  • Candidate must be a creative thinker who has a track record of problem solving and willingness to work in a dynamic environment.
  • Position requires attention to detail and the ability to quality check all data deliverables.
  • Candidate must have good verbal and written communication skills.

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

Clinician - Icelandic 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.
  • Icelandic native speaker
  • Intermediate or advanced proficiency in English preferred.
  • Ability to work collaboratively within the company.

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

Clinician - Japanese 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.
  • Japanese 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 Senior Project Coordinator provides support and acts as the lead for staff within the Logistics department according to MedAvante SOPs and Sponsor plans, as needed. The Sr. Project Coordinator is the point person for the Logistics department and interfaces between other departments to ensure that there is a seamless assimilation of services.

 

Responsibilities

  • Interface with internal departments, such as Project Management and Clinical Trial Services to ensure procedures are implemented and followed appropriately by the Logistics team.
  • 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).
  • Interact with internal work groups to assist with evaluating project resource needs, processes and timelines as needed.
  • Supports manager with overseeing Logistics staff with day to day operational activities.
  • Recognizes, documents and alerts manager of trends to be addressed.
  • Recommends solutions to streamline the efficiencies of internal department processes and assists with the design and implementation of processes.
  • 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 sties 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.
  • Train staff on Logistics processes as needed (this may include internal staff in Logistics or across departments).
  • Mentor Logistics staff as needed.
  • Independently develops, prepares and delivers internal departmental documents including process related Work Instructions and Guidelines and project documents as needed.
  • Provide timely status reports to internal and external key stakeholders.
  • Review progress of projects and initiates appropriate actions to achieve target objectives.
  • 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 3 years’ 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
 

  • Is proficient with the processes of all MedAvante service offerings and internal systems.
  • Ability to work in a fast-paced environment and support multiple projects concurrently.
  • Ability to work within a project team.
  • Strong planning, organization and problem solving abilities.
  • Strong communication skills, oral and written.
  • Proficient in MS Office, specifically Word, Excel andOutlook.
  • 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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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 - 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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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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