Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management Senior Manager, Clinical Data Management Apply locations Princeton - NJ - US time type Full time posted on Posted 4 Days Ago job requisition id R1589774 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. 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. Role Overview: Senior Manager, Clinical Data Management, Bristol-Myers Squibb Company, Princeton, NJ. Provide clinical data management leadership within the study team to align and drive data collection requirements for complex clinical development projects. Plan, coordinate and deliver complete, high quality and reliable clinical trial data. Responsible for end-to-end clinical data management activities and to serve as a primary point of contact for internal and external study team members. Provide strong project oversight over third party vendor for data management deliverables. Gather content and integration requirements for EDC and engage in close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforce data standard conventions and quality expectations for clinical data per defined processes. Author and review DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization. Chair Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness. Represent Data Management on cross-functional project team and submission Team. Lead or support the Health Authority inspection and audit. Provide coaching and quality oversight to junior Data Management Leads. Act as core member of the study team and provide FSP/CRO/Vendor oversight for end-to-end Data Management activities. Manage data currency throughout the trial, and monitor DM deliverables according to the Service Level Agreement (SLA). Provide relevant support and input to continuous improvement activities within clinical data management, and provide support for CAPA implementation as required. Schedule: 40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. MINIMUM REQUIREMENTS : Bachelor's degree or foreign equivalent degree in Bioanalytical Sciences, Biotechnology, Biology, Microbiology, Statistics, Biostatistics or a related field, and five (5) years of related work experience. Must have experience with/in: Medidata RAVE; Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management; EDC systems; Project management; Metrics analysis and reporting methodologies; Knowledge of Submission requirements for New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA). The required skills do not need to be maintained over the full term of required experience. May telecommute to Princeton, NJ from any U.S. location. The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. #J-18808-Ljbffr

Created: 2025-03-07