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Senior Tmf Lead

3-7 years
Not Disclosed
10 May 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Trial Master File (TMF) Coordinator

About ICON:

At ICON, our diverse teams are united by our mission to advance and improve patients’ lives through clinical research. With a focus on Accountability & Delivery, Collaboration, Partnership, and Integrity, we strive to be the partner of choice in drug development. We value process improvement and seek individuals who share our vision and commitment to excellence.

Responsibilities:

  1. Ensure Compliance with ICON Values:

    • Embrace and contribute to ICON's culture of excellence and process improvement.
  2. Documentation Management:

    • Develop and implement Trial Master File (TMF) specifications aligned with program strategies and milestones.
    • Assist in responses to regulatory authorities regarding documentation management for audits, questions, and issues.
    • Review data quality and audit outputs to identify trends and ensure consistency across programs.
  3. Standardization and Improvement:

    • Ensure consistent use of standardized processes and systems across all clinical trials.
    • Identify and implement continuous improvement opportunities to enhance operational efficiency.
  4. Audits and Inspections:

    • Serve as a point of contact for internal and external audits related to study TMF queries.
    • Support the preparation of audit and inspection responses.
  5. Education and Support:

    • Provide guidance and support to the TMF Owner Group to drive performance and resolve guidance conflicts.
    • Educate and mentor team members on good document management practices for clinical trials.
  6. Collaboration and Communication:

    • Facilitate communication among internal and external stakeholders regarding TMF matters.
    • Collaborate with TMF Owners, Sponsors, Vendors, and Study Team Members to ensure TMF readiness and compliance.

Benefits of Working at ICON:

  • Competitive salary packages and annual bonuses based on performance.
  • Comprehensive health-related benefits and retirement plans.
  • A supportive environment that encourages personal fulfillment and drives lasting change.

Equal Opportunity Statement:

ICON is an equal opportunity and inclusive employer committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require a reasonable accommodation during the application process or to perform essential job functions due to a medical condition or disability, please inform us through the provided form.