FSP Clinical Trial Coordinator - eTMF
Thermo Fisher Scientific · Hyderabad · onsite · Posted 2d ago
Undisclosed5–10 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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.
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.
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
- Bachelors 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.
This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Access Managementclinical researchclinical trialsgoogle cloud platformClinical OperationsEtmfregulatory documentationPharmacyBiotechnologyLogisticsRegulatory ComplianceoperationsAdministrationcompliancePharmaceuticalLife Sciences
About Thermo Fisher Scientific
Thermo Fisher Scientific
Biotechnology
4.8k+
employees
1956
70 years old
Waltham,Massachusetts
United States
About
Thermo Fisher Scientific enables their customers to make the world healthier, cleaner and safer.
Industries
BiotechnologyBiotech & Life sciencesInternetAnalytics & KPOPharma
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Culture
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Career growth
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