Associate Director, Standards and Systems, Clinical Data Management

At Genmab we are dedicated to building extranotordinary 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 Genmabs 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 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 Genmabs 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

Bachelors 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 Genmabs 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 and follow us on LinkedIn and X.

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