Note: The job is a remote job and is open to candidates in USA. Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. The Senior Manager, Clinical Programming is responsible for establishing and governing data standards for clinical trials, ensuring compliance with CDISC and regulatory requirements, and managing cross-functional teams to uphold data quality across global programs.
Responsibilities
- Develops and implements company Study Data Tabulation Model (SDTM) standards that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, and analysis
- Ensures alignment of SDTM standards with data collection standards and relevant company tools/system requirements by reviewing study eCRFs, supporting creation of external data collection standards, and providing SDTM mapping guidance
- Serves as a subject matter expert on all aspects of standards development that includes industry standards (CDISC), regulations, and processes
- Ensures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity
- Directly supports knowledge development of others as a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications
- Creates quality control processes, metrics and other measures to ensure compliance with standards
- Ensures work carried out in accordance with applicable SOP’s and working practices, as well as global agency regulations/guidance’s
- Creates any needed documentation and training for standard processes, change control management and tools
- Responsible for defining standards specifications working closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements)
- Facilitates a culture of continuous process improvement and a high level of customer service by maintaining and improving the standards processes associated with standards creation, maintenance, decision-making and implementation
- Working with Digital Solutions and IT, support the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers
- Serves as a liaison between Clinical Programming and External Data Management to ensure data standardization alignment and proactively resolve external data issues that impact SDTM deliverables
Skills
- Bachelor's degree in Statistics, Computer Science, Life Sciences
- At least 6-8 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency
- Proficient in SAS programming, 6-8 years experience
- Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements
- Demonstrated experience managing multiple tasks, complex projects and working with cross functional teams delivering to project and portfolio timelines and metrics
- Strong verbal and written communication skills; independent and effective working in a multi-study, multi-disciplinary atmosphere in a matrix environment
- Master's degree in Statistics, Computer Science, Life Sciences preferred
- Practical knowledge and experience using R to support clinical trial preferred
- Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation is preferred
Benefits
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Company Overview