Senior Clinical Data Manager

Job Description

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. Take your career farther than you thought possible. Responsibilities will include, but are not limited to: Data Review : Understand and review Protocol along with relevant study specific data review documents. Provide input to data review documents like Protocol Data Review Plan, Data Quality Management Plan Review clinical data listings and prioritize critical data review. Manage and facilitate 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 vendor for resolution of data discrepancies as applicable. Documentation: Filing of appropriate documents in eTMF as per eTMF master plan. Training and Mentorship: Provide Training and mentoring to junior CDM staff. Bachelor s Degree required. Life sciences, Pharmacy or relevant fields preferred. 4 years of experience in Clinical Data Review tasks Able to work on clinical data review tasks Able to work collaboratively on multi-disciplinary project teams. Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills. Strong oral and written communication skills. Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) 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 a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: