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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. Read more: careers.bms.com/working-with-us.

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 (electronic Clinical Outcome Assessments, 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.

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. Salary: $168,930.00 - $194,270.00/yr.

MINIMUM REQUIREMENTS:

Bachelor’s degree or foreign equivalent degree in Information Technology, Biotechnology 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).

May telecommute to Princeton, NJ from any U.S. location.

The required skills do not need to be maintained over the full term of required experience.

​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. For more on benefits, please visit our BMS Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holida