FSP Clinical Trial Coordinator - eTMF

ThermoFisher Scientific; Mumbai; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Clinical Trial Coordinator I(eTMF) to support planning, execution, and administration of global clinical trials. You will manage TMF/eTMF, ISF, CTMS, and regulatory submissions, ensuring audit readiness and compliance with ICH-GCP and SOPs.

Collaborate with study teams, investigators and cross-functional partners to maintain study trackers, generate reports, and ensure timely delivery of trial activities.

Qualifications

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

Responsibilities

• 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.

Skills

Clinical Trial Coordination

eTMF/TMF Management

CTMS & Clinical Systems

Regulatory Documentation

Site Start-up Support

Feasibility & Qualification

ICH-GCP Compliance

MS Office Proficiency

Communication & Documentation

Education

Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related field

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Clinical Trial Coordinator I(eTMF)

Role Summary:

The Clinical Trial Coordinator I supports the planning, execution, and administration of clinical trials by managing trial documentation, clinical systems, site activities, regulatory processes, and study tracking. The role works closely with study teams, investigators, and internal stakeholders to ensure timely, compliant, and high-quality trial delivery.

Key Responsibilities

• 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.

Required Skills

• Clinical Trial Coordination & Clinical Operations

• eTMF/TMF and ISF Management

• CTMS, Activate, and Clinical Systems

• Regulatory Documentation & 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

Education & Experience

• 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.

• Understanding of ICH-GCP, clinical trial processes, and regulatory requirements preferred.

• Hands on work experience in global clinical trials.

• Hands on working experience in eTMF system preferably Veeva.

Hands on working experience in taking minutes of meetings of study calls

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.