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FSP Prin Clinical Trial Coordinator

Role overview

Summary

This role is for a Principal Clinical Trial Coordinator responsible for coordinating and supporting clinical trial activities. You will work closely with various stakeholders to ensure operational excellence and regulatory compliance throughout the study execution process.

Qualifications

  • 6+ years of experience working in clinical trial coordinator role
  • Relevant experience in Clinical Trial Coordination, Clinical Operations, or Clinical Research
  • Strong communication and stakeholder management skills
  • Preferred: Bachelor's degree preferred (Life Sciences, Pharmacy, Clinical Research, or related field)
  • Preferred: Experience with CTMS, eTMF/Veeva Vault, and study documentation management

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.
  • Manage study supplies, investigator files, vendor trackers, and trial systems.

Key facts

Hard skills

Other skills

  • Microsoft Office
  • Communication
  • Relationship Building
  • Independent Thinking

About the company

Thermo Fisher Scientific logo

Thermo Fisher Scientific

  • Biotech & Genomics
  • 10,001+
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

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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.



• Ability to work in a matrix environment
• A proven relationship builder
• An independent thinker
• Ability to manage risk and perform risk escalation appropriately


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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