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    Tmf Specialist

    Ct20
    1 years
    Not Disclosed
    Princeton Junction
    12 June 11, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Opportunity: eTMF System Administrator

    Responsibilities:

    • System Administration:

      • Manage day-to-day system administration and overall system maintenance.
      • Ensure the eTMF training program is current with system and procedure updates.
      • Train all users of the eTMF.

    • Quality and Compliance:

      • Maintain overall quality, maintenance, and completeness of Trial Master Files (TMFs).
      • Identify trends or quality concerns and oversee resolution.
      • Ensure system validation with IT collaboration.
      • Work with Clinical Operations and Regulatory Affairs for regulatory compliance.

    • Liaison Duties:

      • Act as a liaison between Site IRBs and the Clinical team to resolve queries and concerns.
      • Prepare and assist in the submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews.

    • Compliance Monitoring:

      • Investigate deviations and monitor Corrective Actions & Preventive Actions (CAPA) related to non-compliance issues and findings.
      • Oversee TMF maintenance by CROs and ensure final transfer of TMF is sufficient for regulatory filings.

    • Additional Duties:

      • Perform other duties as assigned.

    Qualifications:

    • Educational Background:

      • Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or related field.

    • Experience:

      • Minimum of 1 year of clinical research experience in academic and/or industry settings.
      • Prior eTMF/Veeva administration experience required.
      • Knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and International Council for Harmonization E6(R2).

    • Technical Skills:

      • Direct experience with Trial Master Files and electronic TMF systems.

    • Preferred Skills:

      • Fundamental knowledge of clinical trial conduct.

    • Personal Attributes:

      • Strong focus on teamwork, attention to detail, and excellent organizational skills.
      • Ability to prioritize and work in a multi-task environment.
      • Must be able to work independently and professionally.

    Join our team to ensure the highest quality and compliance in clinical research. Your expertise in eTMF systems will contribute to the successful management and administration of critical trial documentation.

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