About this role
About the Role This hybrid, office-based TMF Specialist role is based in Chennai, India, and focuses on processing and managing Trial Master File (TMF) documents to support client services contracts and ICON business needs. You will ensure documents are processed in accordance with study requirements, ICON SOPs/WPs, and applicable regulations, and collaborate with study teams to maintain compliant study files. What You'll Do
- Process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs and regulations.
- Liaise with study teams and other TMF staff to fulfill job responsibilities and activities.
- Complete departmental projects within specified timelines, aligned with ICON SOPs/WPs and regulations.
- Maintain study files per study/client requirements or ICON SOPs/WPs and applicable regulations.
- Complete activities related to document receipt and processing (receipt/review, scanning/indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving).
- Provide information necessary to complete client/department status reports as requested by TMF management.
- Inform the Manager of training issues, project activities, quality issues and timelines.
- Provide copies of study documents to ICON or client personnel as requested.
- Participate in client and/or ICON audits and document archiving activities as necessary.
- Participate in training related to fulfillment of responsibilities as required by ICON and/or the client.
- Liaise with Clients on project issues when directed by the Manager.
- Handle special projects or duties as requested by the Manager. What We're Looking For
- 1-15 years of TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents.
- Ability to successfully liaise with study project teams, staff, clients and management.
- Good oral and written communication skills and interpersonal skills.
- Bachelor's Degree in Life Science preferred. Nice to Have
- Experience participating in client and/or ICON audits.
- Experience supporting document archiving and TMF systems. Compensation & Benefits
- Competitive salary and benefits.
- Various annual leave entitlements.
- Health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals.
- Life assurance.
- Flexible country-specific optional benefits (e.g., childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others).