FSP Prin Clinical Trial Coordinator

Overview

Principal Clinical Trial Coordinator responsible for coordinating and supporting end-to-end clinical trial activities, ensuring operational excellence, regulatory compliance, and timely study execution.

What you'll do

• 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.
• Manage end to end eTMF activities (setup, filing, maintaining, finalising).
• Coordinate with global project managers, onsite monitors, and sites.
• Write plans for study by coordinating with internal and external stakeholders.

What you'll need

• Clinical Trial Operations experience.
• CTMS and eTMF/TMF management experience.
• Regulatory documentation and ICH-GCP knowledge.
• Meeting coordination and minutes of meetings experience.
• Study tracking and reporting experience.
• Microsoft Office Suite proficiency.
• Strong communication and stakeholder management skills.
• Relevant experience in Clinical Trial Coordination, Clinical Operations, or Clinical Research.
• 6+ years of experience working in a clinical trial coordinator role.

Nice to have

• Bachelor's degree in Life Sciences, Pharmacy, Clinical Research, or related field.
• Veeva Vault experience.
• Experience with CTMS, eTMF/Veeva Vault, and study documentation management.

Details

• Work schedule: Standard (Mon-Fri).
• Environmental conditions: Office.
• Location: Mumbai, India.