FSP Prin Clinical Trial Coordinator
Thermo Fisher Scientific · Hyderabad · onsite · Posted 2d ago
Undisclosed6–11 yrsfulltimeSourced from
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About this role
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
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.
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
- Bachelors 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.
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
clinical researchclinical trialsMeeting Coordinationgoogle cloud platformClinical OperationsEtmfregulatory documentationPharmacyMicrosoft Office SuiteRegulatory ComplianceDocument CollectionoperationscompliancePharmaceuticalLife 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
Employee ratings
1,052 reviews
3.8/ 5
Culture
3.7
Career growth
3.0
Work-life
3.8
Employees rate it well for
Work Life Balance177Work Culture134Senior Management98Salary96Career Growth65
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