PHARMAFull-time
Senior Clinical Trial Coordinator
INDIA (IN)HYBRIDPOSTED: 8/15/2026
PHARMAFull-time
HIRING ORGANIZATIONTHERMO FISHER SCIENTIFICLife Sciences / Scientific Instruments / Biotechnology
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Clinical Trial Coordination & Oversight: Coordinate, oversee, and execute trial deliverables across central and local site activities in adherence to assigned task matrices, project timelines, and budgetary requirements.
Trial Master File ((e)TMF) Management: Maintain, review, and ensure audit-readiness of electronic Trial Master Files ((e)TMF), Investigator Site Files (ISF), and pharmacy binders according to established review schedules and SOPs.
Regulatory & IRB/IEC Documentation: Review, track, reconcile, and transmit local regulatory submissions and study documents to clients and centralized Institutional Review Boards / Independent Ethics Committees (IRB/IEC).
System & Vendor Tracking: Provide administrative and operational system support across clinical trial management platforms (e.g., GoBalto, eTMF), manage user access provisioning, update project trackers, and support Risk-Based Monitoring (RBM) activities.
Study Support & Mentorship: Facilitate study meetings, author comprehensive minutes, compile metric finding reports, coordinate clinical/non-clinical supplies distribution, and serve as an onboarding buddy/trainer for junior trial coordinators.
Technical & Domain Standards
Strong understanding of ICH Good Clinical Practice (ICH-GCP), local regulatory requirements, and standard operating procedures (SOPs/WPDs).
Proficiency in clinical documentation quality control, translation review, and study metric reconciliation.
REQUIRED VERIFIED SKILLS
Clinical Trial Coordination
eTMF Management
ICH-GCP
Regulatory Document Tracking
IRB/IEC Submissions
Investigator Site File (ISF)
Risk-Based Monitoring (RBM)
Study Metrics Reconciliation
Clinical Operations
COMPENSATION & REWARDS
₹6.5L - 11.0L per annum
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global leader in serving science, providing an extensive range of analytical instruments, laboratory equipment, reagents, consumables, software, and services. They partner with pharmaceutical and biotech companies, hospitals, clinical diagnostic labs, universities, research institutions, and government agencies. The company's mission is to enable its customers to make the world healthier, cleaner, and safer.
TEAM SIZE: 130,000+ employees
INDUSTRY: Life Sciences / Scientific Instruments / Biotechnology
RECOMMENDED TRAINING
1/5
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