Bristol Myers Squibb Senior Clinical Data Manager
Location: Hyderabad, Telangana, India
Job Description
Working with Us:
Join Bristol Myers Squibb for a challenging, meaningful, and life-changing career. Here, every day is an opportunity to transform lives through uniquely interesting work across various departments.
Functional Area Description:
Clinical Data Management (CDM) ensures the integrity, reliability, completeness, and quality of clinical trial data, providing end-to-end leadership for trials across the BMS R&D portfolio.
Position Summary / Objective:
The Senior Clinical Data Manager is a key member of the CDM team, responsible for data review tasks on assigned studies. This is a full-time office-based position with flexibility to work remotely up to 50% of the time.
Position Responsibilities:
- Data Review:
- Understand and review protocols and study-specific data review documents.
- Provide input to data review documents such as Protocol Data Review Plan and Data Quality Management Plan.
- Review clinical data listings and prioritize critical data review.
- Manage and resolve data discrepancies.
- Perform data cleaning as per the defined Clean Patient Group.
- Coordinate with Data Management Lead for study deliverables.
- Freezing & Locking of CRFs/Fields.
- External Data:
- Track data load and address discrepancies.
- Review loaded external data, prioritize complex reviews.
- Coordinate with external data vendors for discrepancy resolution.
- Documentation:
- File documents in eTMF as per master plan.
- Training and Mentorship:
- Provide training and mentoring to junior CDM staff.
Degree Requirements:
- Bachelor’s Degree required (Life sciences, Pharmacy, or relevant fields preferred).
Experience Requirements:
- 4 years of experience in Clinical Data Review tasks.
Key Competency Requirements:
- Proficiency in clinical data review tasks.
- Collaborative ability on multi-disciplinary project teams.
- Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines, and industry-standard practices.
- Expertise in EDC systems (Medidata RAVE preferred) and Microsoft Office.
- Strong oral and written communication skills.
Travel Required:
- Yes, 5-10% for industry conferences, investigator meetings, and regulatory inspections.
Work Environment:
- No exposure to hazards or disagreeable conditions.
On-site Protocol
| Role Type | Work Model |
|---|---|
| Site-essential | 100% onsite at your assigned facility |
| Site-by-design | Eligible for a hybrid model with at least 50% onsite |
| Field-based | Ability to travel for business needs and meetings as directed |
| Remote-by-design | Ability to travel for business needs and meetings as directed |
Why BMS?
Our single vision is “Transforming patients’ lives through science™.” BMS employees are empowered to apply their talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials. Our values of passion, innovation, urgency, accountability, inclusion, and integrity drive our success.
Meta Description: Join Bristol Myers Squibb as a Senior Clinical Data Manager in Hyderabad for a life-changing career in clinical data management.