Global Clinical Document Compliance: Bristol Myers Squibb Hiring eTMF Operation Analyst

Bristol Myers Squibb (BMS), a leading global biopharmaceutical company, is actively seeking a eTMF Operation Analyst to join its team in Hyderabad, India. This role is foundational to ensuring the integrity and compliance of essential clinical trial documentation, a vital component for global regulatory submissions and inspections.

The position offers a competitive and flexible work environment, aligning with BMS’s commitment to work-life balance and comprehensive employee benefits.

Role Overview and Core Responsibilities

The eTMF Operation Analyst is responsible for the meticulous management and quality control of clinical trial documents within the Electronic Trial Master File (eTMF), primarily focusing on maintaining a state of real-time inspection readiness.

Key responsibilities for this compliance-focused role include:

Document and Quality Compliance: Applying extensive knowledge of ALCOA+ standards (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Enduring, Available), Good Clinical Practice (GCP), Good Documentation Practices (GDP), and ICH guidelines (E6(R2)) to all documentation processes.
Clinical Content Management: Managing clinical content within the eTMF system, which serves as the central repository for all essential trial documents.
Critical Quality Review: Utilizing critical thinking skills to actively conceptualize, apply, analyze, and evaluate information gathered during the quality review process to ensure all documentation is complete, accurate, and compliant, directly influencing quality review decision-making.
Communication: Maintaining strong written and verbal communication to effectively interact with various clinical trial stakeholders and internal teams.

Candidate Requirements and Qualifications

The ideal candidate will possess specialized experience in clinical documentation and records management, with a preference for specific industry tools.

Essential Candidate Profile:

Experience: A minimum of 3–5 years of professional experience in eTMF operations and clinical trials.
eTMF System Knowledge: Prior experience with an electronic Trial Master File system is required, with a strong preference for experience using Veeva Vault eTMF.
Project Management: Demonstrated ability to independently manage projects and handle concurrent tasks within a fast-paced environment.
Education: A minimum of a Bachelor’s degree in a scientific or a related discipline (e.g., Life Sciences, Pharmacy, Clinical Research).

Job Details and Application Information

Location: Hyderabad, India 🇮🇳
Industry Type: Pharma/Healthcare/Clinical research
Experience Required: 3–5 years
Qualification: Bachelor’s degree
Application Deadline: 25th October 2025

This position is a key opportunity to join the global Drug Development Operations team at BMS, contributing directly to the quality and efficiency of clinical trials that deliver life-changing medicines to patients.

Potential career growth for an eTMF Operations Analyst at BMS can lead to senior roles such as eTMF Specialist/Lead, TMF Process Manager, or roles within Clinical Quality Assurance/Auditing, reflecting an increasing scope of compliance responsibility and team management.