3 Days Left) Senior TMF Lead

4 weeks ago


Bengaluru, Karnataka, India Thepharmadaily 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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