FSP Clinical Trial Coordinator - eTMF

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a 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.

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.

Welcome

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

About Us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.