FSP Prin Clinical Trial Coordinator
Company: Thermo Fisher Scientific
- Location: Andhra Pradesh, India
- Seniority: Senior
- Employment type: Full-time
- Posted: Today
- Offer language: English
Job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Principal Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
Principle Clinical Trial Coordinator
Role Summary:
Responsible for coordinating and supporting end-to-end clinical trial activities, ensuring operational excellence, regulatory compliance, and timely study execution. Works closely with CTLs, CTMs, investigators, vendors, and cross-functional teams to manage trial documentation, systems, reporting, and stakeholder communication.
Key Responsibilities
- Coordinate and track study activities, timelines, and deliverables.
- Maintain and review eTMF/TMF, CTMS, study trackers, and trial documentation.
- Support regulatory submissions, audit readiness, and compliance with ICH-GCP and SOPs.
- Schedule meetings, prepare meeting minutes, and facilitate communication across study teams.
- Manage study supplies, investigator files, vendor trackers, and trial systems.
- Compile and analyze study metrics, reports, and operational data.
- Support site activation, feasibility, and document collection activities as required.
Required Skills
- Clinical Trial Operations
- CTMS & eTMF/TMF Management
- Regulatory Documentation & ICH-GCP
- Meeting Coordination & Minutes of Meetings
- Veeva Vault (preferred)
- Study Tracking & Reporting
- Microsoft Office Suite
- Strong communication and stakeholder management skills
Education & Experience
- Bachelor's degree preferred (Life Sciences, Pharmacy, Clinical Research, or related field).
- Relevant experience in Clinical Trial Coordination, Clinical Operations, or Clinical Research.
- Experience with CTMS, eTMF/Veeva Vault, and study documentation management preferred
- 6+ years of experience working in clinical trial coordinator role.
- Hands on experience in managing end to end eTMF activities (Setup filing, Maintaining, Finalising)
- Hands on work experience in coordinating with global project managers, onsite monitors, sites.
- Hands on work experience in writing plans for study by coordinating with internal and external stakeholders.
