Senior Manager, Clinical Data Management

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. 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 (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.

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. 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 holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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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, while 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 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:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

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.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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