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Thermo Fisher ScientificBiotechnology

FSP Prin Clinical Trial Coordinator

India , Mumbai
Full-time

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.


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