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Senior TMF Lead

3 - 7 years

8 - 13 Lacs

Bengaluru Karnataka India

Posted:2 days ago| Platform: Foundit logo

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Skills Required

TMF management clinical trial documentation audit readiness Regulatory Compliance document quality review

Work Mode

On-site

Job Type

Full Time

Job Description

Ensure Compliance with ICON Values:

  • Embrace and contribute to ICONs culture of excellence and process improvement.

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.

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.

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.

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.

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

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