Associate Director, Standards and Systems, Clinical Data Management

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! The Role The Associate Director, Standards and Systems is operationally responsible for the development, maintenance and adherence to Genmab’s clinical data standards including eCRFs, edit checks, electronic case report forms (eCRFs) Completion Guidelines, controlled terminology, CDISC, CDASH and etc. The Associate Director provides leadership for the continued development and enforcement of data standards through extensive collaboration with Data Management, Clinical Programming, Medical, Stats and other cross-functional teams where needed. The Associate Director works to implement data standards after an extensive upstream/downstream impact is assessed, maintaining consistency with related supportive processes to ensure accurate and seamless use of end-to-end Genmab standards.

Summary

The Associate Director, Standards and Systems has expertise in the development of eCRFs for complex oncology clinical trials and Industry standards (CDISC, CDASH, SDTM). This includes the development of the eCRF technical specifications, overseeing external vendors in the development of the eCRF/Clinical Database and contribution to the design of new data capture forms. This role understands the complex and interdependent relationships between protocol development, data collection and analysis and reporting and provides EDC technical expertise to ensure proper eCRF design and database builds during initial database release and during post-production changes. Additionally, this role is responsible for the establishment, governance, and integrity of clinical trial data collection standards in the EDC/Clinical Database. This role will participate in and drive implementation of lessons learned and the development of new, innovative procedures to ensure high quality standards are developed and maintained. This role will lead improvement initiatives for standards and systems related processes, which may involve cross departmental stakeholders to ensure quality standards defined by regulation, industry best practices, Genmab SOPs and ICH-GCP. The Associate Director will lead the design and maintenance of standard eCRFs, metadata libraries, and configuration templates within EDC platforms (e.g., Medidata Rave), ensuring scalability, reuse, and compliance with regulatory and submission expectations and will oversee change control processes, version management, and lifecycle governance of eCRF components within the Global Library. This role will ensure traceability and alignment across programs and provide oversight and expert guidance on study build strategy and configuration. This role will serve as a senior escalation point for issues related to form design, standards deviations, or system configuration inconsistencies, and ensure resolution and alignment with standards governance requirements. Responsibilities • Drive the implementation of standardized and consistent data management activities across the portfolio • Provide strategic leadership and subject matter expertise in the development, implementation, and governance of CRF standards and data management systems to ensure high-quality, consistent data collection across Genmab’s clinical trials • Act as a subject matter expert (SME) for clinical data standards, including eCRF design, edit checks, visit structures, and controlled terminology, ensuring alignment with CDISC standards (e.g., CDASH) and internal best practices • Lead the design and maintenance of standard CRFs, metadata libraries, and configuration templates within EDC platforms (e.g., Medidata Rave), ensuring scalability, reuse, and compliance with regulatory and submission expectations • Collaborate cross-functionally with stakeholders such as Data Management, Biostatistics, Programming, Trial Strategy & Delivery (TSD), and Medical to ensure data collection standards support end-to-end clinical development goals • Oversee change control processes, version management, and lifecycle governance of CRF components within the Global Library, ensuring traceability and alignment across progr Apply tot his job Apply To this Job