FSP Prin Clinical Trial Coordinator

ThermoFisher Scientific; Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Principal Clinical Trial Coordinator to oversee end-to-end clinical trial activities with focus on operational excellence and regulatory compliance. You will work with CTLs, CTMs, investigators, vendors and cross-functional teams to manage documentation, systems and reporting.

Responsibilities include maintaining eTMF/CTMS, supporting regulatory submissions, and coordinating site activation while ensuring timelines and quality standards are met in a global

Qualifications

• Bachelor's degree preferred in Life Sciences, Pharmacy, Clinical Research or related field.
• Minimum 6+ years in clinical trial coordination or clinical operations.
• 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 and trial documentation.
• Support regulatory submissions, audit readiness and ICH-GCP compliance.
• Schedule meetings, prepare minutes and facilitate cross-team communication.
• 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.

Skills

Clinical Trial Operations

CTMS & eTMF/TMF Management

Regulatory Documentation & ICH-GCP

Meeting Coordination & Minutes

Veeva Vault (preferred)

Study Tracking & Reporting

Microsoft Office Suite

Stakeholder Management

Education

Bachelor's degree in Life Sciences/Pharmacy/Clinical Research

Tools

CTMS

eTMF/Veeva Vault

Study Documentation Management

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.

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.