Senior Manager, Clinical Data Standards
About The Position
Bristol Myers Squibb is seeking a Senior Manager, Clinical Data Standards to lead the development and maintenance of global clinical data standards. This role ensures alignment with industry frameworks like CDISC, SDTM, and controlled terminology. The position involves overseeing the creation of metadata, mappings between operational and SDTM standards, and documenting standard usage. The Senior Manager will act as a subject matter expert in study and project team meetings, providing input on various aspects of data management, and serve as a consulting resource for project teams on operational data standards, SDTM, ADaM, and CDISC controlled terminology. Additionally, the role supports the validation of SDTM domains using industry-standard tools and custom validation programs to ensure data integrity and compliance.
Requirements
- Bachelor’s degree or foreign equivalent degree in Bioinformatics, Microbiology, or a related field and seven (7) years of post-bachelor, progressive, work experience as a Clinical Data Manager or related occupation.
- Seven (7) years of experience with/in the pharmaceutical development process.
- Seven (7) years of experience in creating data mapping specifications utilizing industry standards, including Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Models (SDTM), or Analysis Data Models (ADaM).
- Seven (7) years of experience with Medidata Rave and Metadata Repository.
- Seven (7) years of experience interpreting and complying with Health Authority regulations.
- Seven (7) years of experience with submission requirements, including annotated Case Report Forms, XPT files, and define.xml.
Responsibilities
- Lead the development and maintenance of global clinical data standards, ensuring alignment with industry frameworks such as the Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), and controlled terminology.
- Oversee the creation of metadata, mappings between operational and SDTM standards, and documentation of standard usage.
- Serve as a subject matter expert in study and project team meetings, providing input on Case Report Form (CRF) design, CRF Completion Guidelines, programmed edit checks, data transfer specifications, SDTM mapping specifications, and annotated CRFs.
- Act as a consulting resource for project teams on operational data standards, SDTM, Analysis Data Model (ADaM), and CDISC controlled terminology.
- Support the validation of SDTM domains, leveraging industry-standard tools and custom validation programs to ensure data integrity and compliance.
Benefits
- Annual discretionary bonus
- Medical, pharmacy, dental, and vision care
- BMS Well-Being Account
- BMS Living Life Better
- Employee Assistance Programs (EAP)
- 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
- Survivor support
- Flexible time off (unlimited, with manager approval) for US Exempt Employees
- 11 paid national holidays (with exceptions)
- 160 hours annual paid vacation for new hires (with manager approval) for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees
- 3 optional holidays
- Unlimited paid sick time (based on eligibility)
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day
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What This Job Offers
Job Type
Full-time
Career Level
Manager
