AssociateDirector, Clinical Data ManagementSummaryThe Associate Director, Clinical Data Management, will play a crucial role in our data management efforts, ensuring the accuracy, consistency, and integrity of clinical data. This position involves leading and overseeing all aspects of data management, from planning and coordination to execution and quality control. The successful candidate will be responsible for managing relationships with external partners and collaborating across cross-functional teams to ensure data deliverables and expectations are met.
Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.
- Provide data management leadership, insight, and support to all internal and external projects and clinical trials.
- May simultaneously function as lead Clinical Data Manger for multiple clinical trials.
- Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
- Manage and provide oversight of data management personnel and activities of CROs and vendors.
- Ensure CRO adherence to project timelines, from study startup to study closeout, while maintaining high quality and integrity of deliverables.
- Engage in cross-functional meetings, providing updates on project status, issues, and milestones.
- Review data using listings and visualization tools for performance and quality reporting, conducting reviews within studies and across multiple studies for trend analysis.
- Lead interactions with third-party vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study-specific data.
- Proficient in clinical systems, including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed.
- Contribute to SOP development and updates to meet regulatory compliance and operational needs.
- 10% of travel required.
Basic Qualifications- Bachelor's degree
- Minimum of 6 years of data management experience in pharmaceutical/biotech/CRO industry
- Extensive hands-on experience in all aspects of data management.
Preferred Qualifications- Bachelor's degree in Life Science, mathematics, or health-related fields
- Experience in the Oncology therapeutic area
Skills and Qualifications- Proven ability to manage CRO relationships and oversee data management deliverables.
- 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.
- Applies AI to improve team execution and decision-making
Physical DemandsWhile performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific visual abilities required for this job include close vision and distance vision.
Work EnvironmentThe noise level in the work environment is usually moderate.
Compensation Overview:Remote - United States - US: $173,217 - $209,899
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: The 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 SquibbRayzeBio 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.
R1604559 : Associate Director, Clinical Data Management
