TMF Specialist II, TMF Specialist III and Sr. TMF
TMF Specialist with 2-4 years of experience in TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents. Ability to successfully liaise with study project teams, staff, clients and management, as necessary.
Educational Qualification: Bachelors Degree in Life Science preferred.
Location : Chennai and Bangalore.
TMF Specialist II
Reviewing and processing clinical trial documents to ensure accuracy, completeness, and timeliness.
Supporting study teams with TMF document uploads, tracking, and issue resolution.
Performing routine quality control (QC) checks and assisting in TMF audits or inspections.
Collaborating with internal teams to ensure ongoing TMF compliance.
TMF Specialist III
Leading TMF set-up, maintenance, and close-out for assigned clinical trials.
Acting as a point of contact for TMF-related queries and escalations.
Performing advanced QC checks, identifying trends, and implementing corrective actions.
Training and mentoring junior TMF team members.
Ensuring inspection-readiness and supporting sponsor audits and regulatory inspections.
Senior TMF Specialist
Overseeing TMF management activities across global studies and therapeutic areas.
Driving TMF process improvements and implementing best practices.
Leading initiatives to enhance TMF quality, compliance, and efficiency.
Supporting regulatory inspections with detailed TMF knowledge and documentation.
Providing guidance and leadership to TMF teams and stakeholders.
For further details please reach out to Gayathri.Nareshkumar@iconplc.com