FSP Clinical Trial Coordinator - eTMF

Overview

Supports the planning, execution, and administration of clinical trials by managing trial documentation, clinical systems, site activities, regulatory processes, and study tracking.

What you'll do

• Maintain and manage TMF/eTMF and ISF documentation, ensuring completeness and audit readiness.
• Support study setup and execution by coordinating trial materials, site documentation, and regulatory submissions.
• Manage clinical systems (CTMS, Activate, eTMF), study trackers, reports, and access management.
• Support site qualification, feasibility, site start-up, and investigator documentation activities.
• Coordinate study supplies, vendor interactions, logistics, and site communications.
• Review study metrics, maintain databases, and ensure timely completion of assigned tasks.
• Collaborate with cross-functional teams to ensure compliance with ICH-GCP, SOPs, and regulatory requirements.

What you'll need

• Clinical trial coordination and clinical operations experience.
• eTMF/TMF and ISF management.
• CTMS, Activate, and clinical systems.
• Regulatory documentation and site start-up support.
• Feasibility and site qualification activities.
• ICH-GCP and regulatory compliance.
• MS Office (Excel, Word, PowerPoint, Outlook).
• Strong communication, organization, and documentation skills.
• Bachelor's degree preferred in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related field.
• 1-3 years of experience in Clinical Research, Clinical Operations, or Trial Coordination.

Nice to have

• Understanding of ICH-GCP, clinical trial processes, and regulatory requirements.
• Hands-on work experience in global clinical trials.
• Hands-on working experience in eTMF system, preferably Veeva.
• Hands-on experience taking minutes of meetings of study calls.

Details

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