Thermo Fisher Scientific is hiring for the position of FSP Clinical Trial Coordinator I (eTMF) in Hyderabad, India. The role focuses on clinical trial coordination, Trial Master File (TMF/eTMF) management, regulatory documentation, site start-up activities, and clinical trial systems.
Candidates with 1–3 years of experience in clinical research, clinical operations, or trial coordination, along with hands-on experience in global clinical trials and eTMF systems, can apply.
Job Details
| Particulars | Details |
|---|---|
| Company | Thermo Fisher Scientific |
| Job Title | FSP Clinical Trial Coordinator I (eTMF) |
| Job ID | R-01375033 |
| Location | Hyderabad, India |
| Work Mode | Fully Remote |
| Employment Type | Full-Time |
| Work Schedule | Monday to Friday |
| Experience | 1–3 Years |
| Qualification | Bachelor’s Degree |
| Domain | Clinical Research / Clinical Operations |
| Department | Clinical Trial Operations |
Position
FSP Clinical Trial Coordinator I (eTMF)
The selected candidate will support clinical trial planning, execution, and administration by maintaining trial documentation, coordinating site activities, managing clinical systems, and ensuring compliance with ICH-GCP and regulatory requirements.
Key Responsibilities
- Maintain and manage TMF/eTMF and Investigator Site File (ISF) documentation, ensuring completeness and audit readiness.
- Support clinical study setup and execution, including trial materials, site documentation, and regulatory submissions.
- Manage clinical trial systems, including CTMS, Activate, and eTMF.
- Maintain study trackers, reports, databases, and system access.
- Support site qualification, feasibility, site start-up, and investigator documentation activities.
- Coordinate study supplies, vendor interactions, logistics, and site communications.
- Review study metrics and ensure timely completion of assigned tasks.
- Collaborate with cross-functional teams to maintain compliance with ICH-GCP, SOPs, and regulatory requirements.
- Participate in study calls and prepare meeting minutes.
Eligibility Criteria & Qualifications
Candidates applying for the Clinical Trial Coordinator eTMF position should meet the following requirements:
- Bachelor’s degree preferred in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related field.
- 1–3 years of experience in Clinical Research, Clinical Operations, or Trial Coordination.
- Understanding of ICH-GCP, clinical trial processes, and regulatory requirements.
- Hands-on experience working on global clinical trials.
- Hands-on experience with eTMF systems, preferably Veeva.
- Experience taking minutes of meetings during study calls.
Required Skills
- Clinical Trial Coordination
- Clinical Operations
- TMF/eTMF and ISF Documentation Management
- CTMS and Activate
- Veeva eTMF
- Regulatory Documentation
- Site Start-up and Site Qualification
- Feasibility Activities
- ICH-GCP Compliance
- Clinical Study Tracking and Reporting
- MS Excel, Word, PowerPoint, and Outlook
- Communication and Documentation Skills
- Meeting Minutes Preparation
