Ranjitha Mingi Email & Phone Number

Alpharetta, Georgia, United States

• This involves creating, updating, and managing the TMF throughout the lifecycle of the clinical trial.
• Ensuring that all documents within the TMF comply with regulatory requirements, including Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and local regulations.
• Tracking the receipt, distribution, and completion of essential documents and ensuring that they are filed correctly and in a timely manner. Reviewing documents for completeness and accuracy.
• Conducting regular quality control checks to ensure that the TMF is accurate, up-to-date, and compliant with regulatory standards. Addressing any discrepancies or deficiencies promptly.
• Developing and maintaining Standard Operating Procedures (SOPs) related to TMF management and document handling processes. Ensuring that team members are trained on these procedures and comply with them.
• Collaborating with cross-functional teams including clinical operations, regulatory affairs, data management, and quality assurance to ensure alignment on TMF requirements and documentation standards.

Bengaluru, Karnataka, India