Senior Manager, Clinical Programming
Genmab
5 hours ago
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 the quality and consistency of data standards to support the portfolio objective of data quality and consistency across programs and systems.
Responsibilities:
- Develop and implement company SDTM standards supporting scientific need while ensuring quality, consistency, and compliance to CDISC and other industry standards.
- Align SDTM standards with data collection standards and company tool/system requirements by reviewing study eCRFs, supporting creation of external data collection standards, and providing SDTM mapping guidance.
- Serve as subject matter expert for standards development (CDISC), regulations, and processes.
- Ensure SDTM datasets comply with CDISC and regulatory submission requirements; review study submission data packages for quality and integrity.
- Support others’ knowledge development in data standards, reporting/analysis standards, change control management, and related tools.
- Create quality control processes, metrics, and measures to ensure standards compliance.
- Ensure work follows applicable SOPs/working practices and global agency regulations/guidance.
- Create documentation and training for standard processes, change control management, and tools.
- Define standards specifications with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications, reporting requirements).
- Drive continuous process improvement and customer service for standards creation/maintenance/decision-making/implementation.
- Work with Digital Solutions and IT to implement future strategies and technology-enabled processes/tools for clinical trial standards and standards information exchange.
- Liaison between Clinical Programming and External Data Management to ensure data standardization alignment and resolve external 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 pharmaceutical/biotech/CRO/Regulatory Agency.
- Proficient in SAS programming (6–8 years).
- Practical knowledge/experience using R to support clinical trials (preferred).
- Knowledge of clinical research, metadata management, CDISC, FDA & ICH, GCP, and related regulatory requirements.
- Experience managing multiple tasks and complex projects with cross-functional teams delivering to timelines and metrics.
- Strong verbal and written communication; effective independent work in a matrix environment.
- Experience in clinical data management and/or trial management with technical expertise in standards management/implementation (preferred).
Benefits (US based candidates):
- Proposed salary band: $131,040.00–$196,560.00
- 401(k) plan: 100% match on first 6% contributions
- Health benefits (two medical options including HDHP with HSA), dental, vision
- Voluntary plans: critical illness, accident, hospital indemnity
- Time off: paid vacation, sick leave, holidays, and 12 weeks discretionary paid parental leave
- Support resources: child/adult backup care, family support programs, financial wellness tools, emotional well-being support
- Additional perks: commuter benefits, tuition reimbursement, Lifestyle Spending Account
Responsibilities:
- Develop and implement company SDTM standards supporting scientific need while ensuring quality, consistency, and compliance to CDISC and other industry standards.
- Align SDTM standards with data collection standards and company tool/system requirements by reviewing study eCRFs, supporting creation of external data collection standards, and providing SDTM mapping guidance.
- Serve as subject matter expert for standards development (CDISC), regulations, and processes.
- Ensure SDTM datasets comply with CDISC and regulatory submission requirements; review study submission data packages for quality and integrity.
- Support others’ knowledge development in data standards, reporting/analysis standards, change control management, and related tools.
- Create quality control processes, metrics, and measures to ensure standards compliance.
- Ensure work follows applicable SOPs/working practices and global agency regulations/guidance.
- Create documentation and training for standard processes, change control management, and tools.
- Define standards specifications with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications, reporting requirements).
- Drive continuous process improvement and customer service for standards creation/maintenance/decision-making/implementation.
- Work with Digital Solutions and IT to implement future strategies and technology-enabled processes/tools for clinical trial standards and standards information exchange.
- Liaison between Clinical Programming and External Data Management to ensure data standardization alignment and resolve external 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 pharmaceutical/biotech/CRO/Regulatory Agency.
- Proficient in SAS programming (6–8 years).
- Practical knowledge/experience using R to support clinical trials (preferred).
- Knowledge of clinical research, metadata management, CDISC, FDA & ICH, GCP, and related regulatory requirements.
- Experience managing multiple tasks and complex projects with cross-functional teams delivering to timelines and metrics.
- Strong verbal and written communication; effective independent work in a matrix environment.
- Experience in clinical data management and/or trial management with technical expertise in standards management/implementation (preferred).
Benefits (US based candidates):
- Proposed salary band: $131,040.00–$196,560.00
- 401(k) plan: 100% match on first 6% contributions
- Health benefits (two medical options including HDHP with HSA), dental, vision
- Voluntary plans: critical illness, accident, hospital indemnity
- Time off: paid vacation, sick leave, holidays, and 12 weeks discretionary paid parental leave
- Support resources: child/adult backup care, family support programs, financial wellness tools, emotional well-being support
- Additional perks: commuter benefits, tuition reimbursement, Lifestyle Spending Account