Location - Gurgaon

Job Title

Documentation Specialist

Department / Function

Global Clinical Affairs (GCA) – Clinical Operations

Location

Gurugram, Haryana, India

Reports To

Manager, Clinical Operations / GCA

Employment Type

Full time

Summary

The Documentation Specialist supports the Global Clinical Affairs (GCA) Clinical Operations team by managing the lifecycle of clinical trial and clinical investigation documentation, with a primary focus on the electronic Trial Master File (eTMF). The role ensures that essential documents are complete, accurate, current, and filed in compliance with ISO14155 Good Clinical Practice (GCP) and company Standard Operating Procedures (SOPs). The Documentation Specialist plays a central part in maintaining inspection and audit readiness across the clinical study portfolio.

Responsibilities

Manage the setup, maintenance, quality control, and archival of the electronic Trial Master File (eTMF) for assigned studies, from study start-up through close-out and final archival.
Process clinical documents within the eTMF system:



indexing, classifying, filing, versioning, and tracking documents against the applicable TMF Reference Model and study-specific TMF plans.
Perform completeness, quality, and consistency reviews of incoming documents, identifying missing, expired, or non-compliant records and following up with document owners for resolution.
Collaborate as needed with each assigned study team to determine which study documents need to be collected before, during, and after study conduct, aligned with GCA TMF SOP and established work instructions. Liaise with study team to collect documents at appropriate timepoints.
Maintain GCA’s TMF tracker to ensure transparency of TMF compliance status and action items. escalate gaps and risks to Clinical Operations leadership.
Support inspection and audit readiness by ensuring the eTMF is continuously current, and assist in the preparation, retrieval, and review of documents during int

📌 Documentation Specialist I- Clinical Affairs (Gurugram)
🏢 Hollister
📍 Gurugram