Senior Manager, Clinical Programming

About the role

The Senior Manager, Clinical Programming at Genmab is responsible for establishing, governing, and ensuring the integrity of Study Data Tabulation Model (SDTM) standards. This role involves sponsor oversight of relevant programming activities on the Biometrics vendor, ensuring data quality and consistency across studies and systems.

Responsibilities

• Develops and implements company SDTM standards that align with scientific needs and regulatory requirements.
• Ensures alignment of SDTM standards with data collection standards and relevant company tools/system requirements.
• Serves as a subject matter expert on SDTM standards, industry standards (CDISC), regulations, and processes.
• Ensures study or portfolio-level SDTM datasets comply with CDISC and regulatory submission requirements.
• 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.
• Facilitates a culture of continuous process improvement and high-level customer service by maintaining and improving standards processes.
• Works with Digital Solutions and IT to implement future strategies and technology-enabled processes for clinical trials standards, change control management, and the exchange of standards information.
• Serves as a 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 degree preferred.
• At least 6-8 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency setting.
• Proficient in SAS programming, with practical knowledge and experience using R for clinical trial support.
• Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements.
• Strong experience managing multiple tasks, complex projects, and working with cross-functional teams.
• Independent and effective working in a multi-study, multi-disciplinary atmosphere.