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 programs
• Provide oversight and expert guidance on study build strategy and configuration, ensuring technical specifications align with protocol requirements and Genmab standards
• Serve as a senior escalation point for issues related to form design, standards deviations, or system configuration inconsistencies, and ensure resolution and alignment with governance expectations
• Mentor and support team members, including Managers and Senior Managers, by providing guidance on standards application, system use, and best practices; may include line management responsibilities
• Contribute to the development and continuous improvement of SOPs, work instructions, job aids, and internal governance documentation related to standards and systems
• Represent the Standards and Systems function in internal governance forums, working groups, and cross-functional initiatives, driving innovation and consistency in clinical data collection practices
• Contribute to the development of best practices/SOPs within Genmab DM, aligned with industry and regulatory best practices
• Ensure operational excellence with DM service providers via cross-trial consistency of key DM processes
• Support filing and submission readiness activities; ensure alignment with regulatory requirements and participate in or lead initiatives to continuously improve Genmab standards requirements, related processes and systems with cross-departmental stakeholders
Requirements
• Bachelor's degree in science or related area (or equivalent)
• 10+ years of Industry Related Experience in clinical data standards, electronic data capture (EDC) systems, clinical data management, or related functions within the pharmaceutical, biotechnology, or CRO industry and a foundational knowledge of data standards and metadata management, including familiarity with industry frameworks such as CDISC (CDASH, SDTM) and controlled terminology
• Proven expertise in the development, deployment, and governance of CRFs, edit checks, visit structures, and controlled terminology, particularly within oncology trials and across multiple phases of clinical development and a demonstrated leadership in the implementation and evolution of data standards frameworks, including alignment with CDISC (CDASH/SDTM), regulatory expectations, and cross-functional clinical trial requirements
• Experience in managing and mentoring staff within a technical function; people management or functional leadership experience strongly preferred with strong project leadership and systems oversight skills, with the ability to drive consistency, performance monitoring, and continuous improvement across internal and vendor-supported study builds
• Skilled in identifying risks, resolving form and system-level issues, and making sound decisions in a complex, matrixed environment, including an in-depth knowledge of clinical trial data management systems and tools, including EDC platforms (e.g., Medidata Rave), CRF design tools, metadata repositories, and standards governance systems; familiarity with data visualization tools or dashboarding platforms is a plus
• Experience with clinical trials and the drug development process
• Significant experience leading data management activities in clinical trials; advanced use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation; advanced understanding of DM strategy
• Experience with CDISC (SDTM); as well as data collection requirements in clinical trials
• Experience and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities and analysis and reporting in clinical trials
• Experience and understanding of GCPs, SOPs, regulatory requirements and good data management practices
• Experience working on early and late-stage submissions as per local/regulatory requirements
• Experience working in and leading cross-functional teams
About You
You are genuinely passionate about our purpose
You bring precision and excellence to all that you do
You believe in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
You take pride in enabling the best work of others on the team
You can grapple with the unknown and be innovative
You have experience working in a fast-growing, dynamic company (or a strong desire to)
You work hard and are not afraid to have a little fun while you do so!
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
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Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.