Job Title: Senior Manager, Clinical Data Standards
Location: Hyderabad, TS, India
Job Summary
The Senior Manager, Clinical Data Standards plays a critical role in developing and maintaining global clinical data standards for Bristol Myers Squibb (BMS). This position is essential for ensuring compliant submissions and supporting the success of the BMS R&D pipeline. The role reports to the Associate Director, Clinical Data Standards (CDS).
Key Responsibilities
Development, Maintenance, and Implementation of Clinical Data Standards
Develop and maintain global clinical data standards, including operational (CRF and non-CRF), CDISC Study Data Tabulation Model (SDTM), controlled terminology, and non-CRF standard data mappings (e.g., lab, ECG).
Create metadata and mappings between operational and SDTM standards, documenting their usage.
Serve as a Subject Matter Expert (SME) for standards components, including CRF design, CRF Completion Guidelines, programmed edit checks, data transfer specifications, SDTM mapping specifications, and SDTM annotated CRF.
Act as a consultant for study teams regarding SDTM domain validation and industry standard validation tools.
Work with metadata repositories, SDTM validation systems, change request systems, and issue tracking systems.
Provide coaching to CROs and vendors on BMS data standards and related processes.
Standards Governance and Submission Support
Process clinical data change requests for new or existing metadata, develop recommendations, and oversee implementation.
Participate in Clinical Data Standards Governance Organization (CDSGO) meetings, partnering with functional stewards and documenting decisions.
Provide guidance on SDTM standards and related submission requirements (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide, XPT files).
Engage in study and submission team meetings to support compliance with data standards.
Other Responsibilities
Contribute to the development of Standard Operating Procedures (SOPs), Working Procedures, guidance documents, and job aids.
Identify, review, evaluate, and implement new technologies for data standards management.
Develop training materials and provide training on CDS-developed processes.
Mentor junior personnel and contract staff as required.
Participate in strategic initiatives, special projects, and process improvements.
Share industry best practices and emerging standards with internal teams.
Qualifications & Experience
Education:
Bachelor’s degree in a relevant field (required).
Advanced degree (preferred).
Experience & Knowledge:
Minimum 7 years of industry experience in clinical trials, with a focus on clinical data standards.
Expertise in CDISC standards (CDASH, SDTM, ADaM) and controlled terminology.
Strong knowledge of Medidata Rave (EDC) and Metadata Repository (MDR) (preferred).
Experience interpreting health authority regulations with a strong compliance background.
Proficiency in CRF design, data validation, SDTM mapping specifications, and define.xml requirements.
Strong communication skills, with the ability to articulate complex data standards issues to diverse teams.
Ability to collaborate effectively with medical personnel, study managers, clinical monitors, data managers, programmers, and statisticians.
Additional Information
On-Site Protocol:
This role follows a hybrid work model (minimum 50% on-site presence required).
On-site presence is essential for collaboration, innovation, and productivity.
Diversity & Inclusion:
BMS is committed to diversity and provides equal employment opportunities.
Workplace accommodations are available upon request.
COVID-19 Policy:
Employees are strongly recommended to be fully vaccinated and up to date with COVID-19 boosters.
Legal & Compliance:
BMS considers qualified applicants with arrest and conviction records as per applicable laws.
All applications are treated in compliance with data privacy regulations.
For more details, visit: careers.bms.com
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