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Senior TMF Lead
ConfidentialBengaluru / Bangalore9 days ago
Job descriptionDevelop 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. Ensure consistent use of standardized processes and systems across all clinical trials. Identify and implement continuous improvement opportunities to enhance operational efficiency. Serve as a point of contact for internal and external audits related to study TMF queries. Support the preparation of audit and inspection responses. 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. 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. 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
Ensure Compliance with ICON Values :
- Embrace and contribute to ICONs culture of excellence and process improvement.
Documentation Management :
Standardization and Improvement :
Audits and Inspections :
Education and Support :
Collaboration and Communication :
Benefits of Working at ICON :
Skills Required
Regulatory Compliance
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Senior Lead • Bengaluru / Bangalore
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