Senior TMF Lead

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