Director, Clinical Data Management

Bristol Myers Squibb
San Diego, CA, United States
3 days ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
10 years minimum
Compensation
$200,980.0
Working hours
Regular working hours

Tech stack

Artificial Intelligence Clinical Data Management Databases Data Transmissions Data Structures Data Strategy Information Technology Data Management Veeva

Job description

The Director, Clinical Data Management will serve as the Clinical Data Management program lead for a new product, providing end-to-end data management leadership across the program’s clinical studies. This role will be accountable for driving data management strategy, execution, quality oversight, and cross-functional alignment from study start-up through database lock, submission support, and inspection readiness. The Director will partner closely with internal study teams, CROs, and external vendors to ensure clinical trial data are complete, reliable, timely, and fit for decision-making, while bringing a hands-on, solutions-oriented approach to program execution and data quality., * Serve as the Clinical Data Management program lead for a new product and lead the individual studies within that program, providing strategic and hands-on data management leadership from study start-up through database lock.

  • Develop and drive the data management strategy for the assigned new-product program, including study start-up planning, database build oversight, data review approach, risk management, database lock, and submission readiness.
  • Lead data management execution at both the program and study level in partnership with study teams, ensuring high-quality, timely, and decision-ready clinical trial data across all studies within the program.
  • Oversee CROs and data management vendors supporting the program and its studies, ensuring clear expectations, accountability, quality, compliance, and adherence to study and program timelines.
  • Partner cross-functionally with Biostatistics, Statistical Programming, Clinical Operations, Medical Monitoring, Safety, Regulatory Affairs, and other stakeholders to align on program priorities, data quality expectations, and deliverables.
  • Lead ongoing cross-functional data review activities and ensure timely identification, escalation, and resolution of data issues, trends, risks, and quality concerns.
  • Oversee or contribute to key data management documentation, including Data Management Plans, edit check specifications, validation plans, reconciliation plans, data transfer agreements, data review plans, and database lock documentation.
  • Willing to travel approximately 10% of the time. Evening and weekend work may be required.
  • Leverages AI to drive program, portfolio, or functional performance through prioritization and scaled adoption

Requirements

  • Strong knowledge and experience of EDC systems (Medidata RAVE or Veeva).
  • Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations.
  • Excellent verbal and written communication skills.
  • Strong analytical and problem-solving abilities.

Basic Requirements:

  • Bachelor’s or Master’s degree in Life Sciences, Computer Science, Mathematics, Health Sciences, or a related field required.
  • Minimum of 10 years data management experience in pharmaceutical/biotech/CRO industry.
  • Demonstrated experience leading study teams, vendors, or direct/indirect reports; ability to guide, mentor, and develop others as applicable.
  • In-depth experience in the Oncology therapeutic area is required.
  • Proven ability to manage CRO relationships and oversee data management deliverables.
  • Experience utilizing AI-enabled tools to improve productivity and work efficiency.

Preferred Requirements:

  • Radiopharmaceutical experience preferred.

Benefits & conditions

Remote - United States - US: $200,980 - $243,544 San Diego - RayzeBio - CA: $217,060 - $263,021

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

? Work-life benefits include:

Paid Time Off

  • US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
  • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

About the company

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact-on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals

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Apply on www.beyondsandiego.com
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