Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Senior Clinical Data Manager
Location: Hyderabad, Telangana, India
Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Functional Area Description
Clinical Data Management (CDM) is responsible for the integrity, reliability, completeness, and quality of clinical trial data and provides end-to-end clinical data management leadership for trials across the BMS R&D portfolio.
Position Summary / Objective
The Senior Clinical Data Manager is a crucial member of the Clinical Data Management team, responsible for completing data review tasks on assigned studies across various therapeutic areas. This role reports to a line manager within CDM and is a full-time office-based position with flexibility to work remotely up to 50% of the time over two weeks.
Position Responsibilities
Responsibilities include, but are not limited to:
- Data Review:
- Understand and review Protocol and relevant study-specific data review documents.
- Provide input to data review documents such as Protocol Data Review Plan, Data Quality Management Plan.
- Review clinical data listings and prioritize critical data review.
- Manage and facilitate the resolution of data discrepancies.
- Perform data cleaning as per the defined Clean Patient Group.
- Freezing & Locking of CRFs/Fields.
- Coordinate with Data Management Lead for study deliverables.
- External Data:
- Track data load and address discrepancies.
- Complete review of loaded external data and prioritize complex external data review e.g., Blinded Independent Committee Review, Biomarker, SAE.
- Coordinate with external data vendors for resolution of data discrepancies as applicable.
- Documentation:
- File appropriate documents in eTMF as per eTMF 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 the Clinical Drug Development Process, FDA/ICH guidelines, and industry-standard practices regarding data management.
- Expertise in EDC systems (Medidata RAVE preferred) and Microsoft Office skills.
- Strong oral and written communication skills.
Travel Required
- Yes, 5-10% for industry conferences, investigator meetings, and regulatory inspections (as needed).
Work Environment
- No exposure to hazards or disagreeable conditions.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™,” every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials. Our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure determining where an employee is required to conduct their work. This includes site-essential, site-by-design, field-based, and remote-by-design roles. The occupancy type assigned to you is based on the nature and responsibilities of your role:
- Site-essential roles: 100% onsite at your assigned facility.
- Site-by-design roles: Eligible for a hybrid work model with at least 50% onsite.
- Field-based and remote-by-design roles: Ability to travel for business needs and meetings as directed is essential.