Senior Manager, Clinical Programming
Genmab
August 24, 2026
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
The Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data Tabulation Model (SDTM) standards, sponsor oversight of relevant programming activities on the Biometrics vendor, and ensuring quality and consistency of data standards across the portfolio.
Responsibilities:
- Develop and implement company SDTM standards ensuring quality, consistency, and compliance with CDISC and other industry standards.
- Align SDTM standards with data collection standards and company tool/system requirements by reviewing eCRFs, supporting creation of external data collection standards, and providing SDTM mapping guidance.
- Serve as SME on standards development (CDISC), regulations, and processes.
- Ensure SDTM datasets comply with CDISC and regulatory submission requirements; review submission data packages for quality and integrity.
- Support knowledge development on data standards, reporting/analysis standards, and change control tools/processes.
- Create quality control processes/metrics to ensure standards compliance.
- Ensure work follows applicable SOPs and global agency regulations/guidance.
- Create documentation and training for standard processes, change control, and tools.
- Define standards specifications with implementation support teams (database setup, completion guidelines, CRF design, procedures, algorithm and reporting requirements).
- Support technology-enabled processes and standards exchange with Digital Solutions/IT.
- Liaison between Clinical Programming and External Data Management to resolve data issues impacting SDTM deliverables.
Requirements:
- Bachelor’s degree in Statistics, Computer Science, or Life Sciences; Master’s preferred.
- 6–8+ years relevant experience in pharma/biotech/CRO/Regulatory Agency.
- Proficient in SAS (6–8 years).
- Practical knowledge of R for clinical trials preferred.
- Knowledge of clinical research, metadata management, CDISC, FDA/ICH, GCP, and regulatory requirements.
- Experience managing multiple complex projects and cross-functional teams.
- Strong verbal and written communication; effective independent work in matrix environments.
- Clinical data management and/or trial management with standards implementation expertise preferred.
Benefits (US first-year, regular full-time employees): 401(k) 100% match on first 6%; health/dental/vision; voluntary plans; paid time off including 12 weeks paid parental leave; child/adult backup care and family support; commuter benefits, tuition reimbursement, and Lifestyle Spending Account.
Responsibilities:
- Develop and implement company SDTM standards ensuring quality, consistency, and compliance with CDISC and other industry standards.
- Align SDTM standards with data collection standards and company tool/system requirements by reviewing eCRFs, supporting creation of external data collection standards, and providing SDTM mapping guidance.
- Serve as SME on standards development (CDISC), regulations, and processes.
- Ensure SDTM datasets comply with CDISC and regulatory submission requirements; review submission data packages for quality and integrity.
- Support knowledge development on data standards, reporting/analysis standards, and change control tools/processes.
- Create quality control processes/metrics to ensure standards compliance.
- Ensure work follows applicable SOPs and global agency regulations/guidance.
- Create documentation and training for standard processes, change control, and tools.
- Define standards specifications with implementation support teams (database setup, completion guidelines, CRF design, procedures, algorithm and reporting requirements).
- Support technology-enabled processes and standards exchange with Digital Solutions/IT.
- Liaison between Clinical Programming and External Data Management to resolve data issues impacting SDTM deliverables.
Requirements:
- Bachelor’s degree in Statistics, Computer Science, or Life Sciences; Master’s preferred.
- 6–8+ years relevant experience in pharma/biotech/CRO/Regulatory Agency.
- Proficient in SAS (6–8 years).
- Practical knowledge of R for clinical trials preferred.
- Knowledge of clinical research, metadata management, CDISC, FDA/ICH, GCP, and regulatory requirements.
- Experience managing multiple complex projects and cross-functional teams.
- Strong verbal and written communication; effective independent work in matrix environments.
- Clinical data management and/or trial management with standards implementation expertise preferred.
Benefits (US first-year, regular full-time employees): 401(k) 100% match on first 6%; health/dental/vision; voluntary plans; paid time off including 12 weeks paid parental leave; child/adult backup care and family support; commuter benefits, tuition reimbursement, and Lifestyle Spending Account.