FSP Prin Clinical Trial Coordinator

FSP Prin Clinical Trial Coordinator

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.

 

Experience Level

Senior Level