Position: eTMF Operation Analyst
Location: Hyderabad (Hybrid)
Industry: Biopharmaceuticals
💼 Working With Us: More Than Just a Job
At Bristol Myers Squibb (BMS), we believe that work should be more than just a routine—it should be challenging, meaningful, and life-changing. Our mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. Every department at BMS contributes to this mission, whether it’s optimising a production line or pioneering breakthroughs in cell therapy.
Working here means being part of a high-performing team that values innovation, collaboration, and personal growth. You’ll have the opportunity to work on projects that impact lives globally, while advancing your own career in ways you never imagined.
We also understand the importance of work-life balance and flexibility. That’s why we offer a wide range of competitive benefits, services, and programs designed to support our employees both professionally and personally. Learn more at careers.bms.com/working-with-us
📌 Position Overview
We are currently hiring for the role of **eTMF Operation Analyst**. This remote position is based in India and is ideal for professionals with experience in clinical trials, electronic Trial Master File (eTMF) systems, and regulatory documentation.
This role plays a critical part in ensuring the integrity, accuracy, and compliance of clinical trial documentation. You’ll be working with global teams, managing clinical content, and supporting quality review processes that align with international standards
🔍 Key Responsibilities
Apply extensive knowledge of ALCOA+ standards, Good Clinical Practice (GCP), Good Documentation Practices, and ICH E6(R2) guidelines.
Act as an critical thinker, using analytical and evaluative skills to support decision-making in quality reviews.
Manage clinical content within records management systems or electronic Trial Master File (eTMF) platforms, preferably Veeva Vault.
Communicate effectively with internal and external stakeholders, both verbally and in writing.
Independently manage multiple projects and tasks in a fast-paced, deadline-driven environment.
Ensure compliance with regulatory requirements and internal SOPs.
Support audits and inspection readiness activities as needed.
🎓 Qualifications & Experience
Education:
Minimum of a Bachelor’s degree in a scientific or related discipline.
Experience:
3–5 years of experience in clinical trials and eTMF systems.
Hands-on experience with Veeva Vault eTMF is highly preferred.
Proven ability to manage projects independently and handle concurrent tasks.
Familiarity with regulatory documentation and clinical trial protocols.
✈️ Travel Requirements Occasional travel may be required based on project needs.
🌐 Why Join Bristol Myers Squibb?
At BMS, you’ll be part of a company that’s committed to transforming patients’ lives through science. You’ll work alongside passionate professionals in an environment that fosters innovation, diversity, and inclusion. Whether you’re just starting your career or looking to take the next step, BMS offers opportunities that are uncommon in scale and scope.
📬 How to Apply
If you’re excited about making a meaningful difference in the world of clinical research and records management, we encourage you to apply today.
👉 Apply here: BMS Careers – eTMF Operation Analyst
✨ Final Note
Take your career farther than you ever imagined. At Bristol Myers Squibb, your work will not only advance your professional journey but also touch the lives of patients worldwide.
Apply today—be part of something extraordinary.