Senior Clinical Data Manager at Genmab Princeton, NJ

Senior Clinical Data Manager

Location:

Princeton, NJ or Copenhagen, Denmark (hybrid). This role supports planning, execution, and completion of clinical trials, provides oversight of Data Management (DM) vendors, ensures compliance with Genmab SOPs and ICH‑GCP, and leads innovation in data management processes.

• Deliver core deliverables such as EDC setup, data collection, validation of data in the clinical database prior to analysis, and ensure deliverables are completed within budget and timelines.
• Oversee DM vendors and their deliverables, including eCRF design, UAT, data management plan, data validation plan, data cleaning activities, and final data transfer specifications.
• Ensure appropriate involvement of stakeholders and maintain effective communication.
• Provide input to clinical development plans, ensuring data management input is considered in trial operational strategy.
• Represent Clinical Data Management in Operational Committees or forums with partners, DM vendors, or other data stakeholders.
• Participate in working groups on data protection regulation, biomarker group setup, ePRO, IRT, and other data management topics.
• Lead alignment meetings within the data management group, ensuring consistent execution across multiple trials.
• Participate in risk‑management discussions related to data management activities.
• Review and provide input to protocol and amendment development, including protocol deviations, randomization and stratification plans, tables, figures, listings, and blinding procedures.
• Attend trial and investigator/monitor meetings as needed.
• Support timely delivery of data management deliverables in accordance with Genmab SOP and ICH‑GCP.
• Maintain dashboards and other reporting tools.
• Support vendor qualification (RFP, bid defense meetings) for data management, ePRO, and IRT activities and specify scope of work.
• Review scope of work for trials and challenge major work orders, change orders, and change notification forms.
• Ensure compliance with regulations, Genmab SOPs, and ICH‑GCP; address escalations to secure trial progress and quality.
• Ensure trial oversight activities follow the trial oversight plan, including eTMF review and risk assessment.
• Participate in audits and inspections, provide root‑cause analysis, and share lessons across trials.
• Support project submission activities such as providing listings and documentation for regulatory submission.
• Lead and contribute to knowledge sharing within the department and across departmental activities.
• Stay current on scientific, process, and technical progress and advise on new methodologies that support innovation and efficiency.
• Contribute to process optimizations and SOP revisions.
• Lead and participate in cross‑functional working groups, projects, and task forces.

• Bachelor’s degree in science or related area.
• 5–8+ years of experience in clinical data management in the biotech/pharma industry, with significant hands‑on end‑to‑end experience.
• Experience with oncology clinical trials preferred.
• Experience with the drug development process and multiple clinical trials.
• Proficient use of data management systems and advanced knowledge of DM processes, tools, and documentation.
• Strong understanding of DM strategy, GCPs, SOPs, regulatory requirements, and good data management practices.
• Project management experience.

• Planning and organization
• Clinical development/trial conduct, including ICH‑GCP
• Team leadership
• Problem solving and decision making
• Effective scientific communication
• Quality mindset
• Document creation and management
• Process development
• Proactive and accountable behavior
• Analytical skills and presentation of clinical data
• IT skills with data management systems
• In‑depth knowledge of regulatory guidelines (FDA, EMA, ICH)

• You are genuinely passionate about our purpose.
• You bring precision and excellence to all that you do.
• You believe in a rooted‑in‑science approach to problem‑solving.
• You are a generous collaborator who can work in diverse teams.
• 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.
• You work hard and are not afraid to have a little fun while you do so.

Genmab offers an agile working environment. The role can be based in Copenhagen, Denmark or Princeton, New Jersey, U.S., and is hybrid.