Bristol Myers Squibb (BMS) is a global biopharmaceutical leader committed to discovering, developing, and delivering innovative medicines for patients battling serious diseases. With a mission to transform patients’ lives through science, BMS fosters a culture of passion, innovation, and inclusion. Employees enjoy unparalleled career growth opportunities, competitive benefits, and a flexible work environment.
Job Description
BMS is hiring a Document Coordinator for Global Trial Acceleration in Hyderabad. This role is critical in managing clinical trial documentation, ensuring compliance, and supporting global study teams.
Key Responsibilities:
- Manage clinical trial document collection, review, and approval across global studies.
- Coordinate with CROs, Country Trial Managers (CTMs), and internal teams for seamless trial execution.
- Oversee ethical and regulatory submissions, ensuring compliance with global standards.
- Support study start-up activities, including site activation and essential document tracking.
- Review Site Monitoring Visit reports, escalate issues, and follow up on resolutions.
- Assist in creating study-specific materials (e.g., Investigator Site Files, pharmacy manuals).
- Maintain clinical systems (CTMS, eTMF) for accurate trial documentation.
- Facilitate certified translations of study documents (ICFs, Protocols, IBs).
- Contribute to Clinical Study Report (CSR) appendices and distribution.
Qualifications & Skills:
- Experience in clinical trial documentation management (pharma/CRO background preferred).
- Strong organizational skills with attention to detail.
- Knowledge of regulatory requirements (ICH-GCP, FDA, EMA).
- Proficiency in clinical trial systems (eTMF, CTMS).
- Excellent communication and stakeholder management skills.
Why Join BMS?
- Impactful Work: Contribute to life-changing therapies.
- Career Growth: Unmatched learning and development opportunities.
- Work-Life Balance: Flexible policies and wellness programs.
- Inclusive Culture: A diverse and collaborative environment.
