Associate Director, Clinical Data Management
Genmab
August 20, 2026
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Responsibilities:
- As “Data Manager,” operationally responsible for planning, start-up, conduct, and closure of clinical trials from final synopsis/CTT assignment.
- Deliver core clinical data management deliverables (e.g., EDC setup, data collection, clinical database validation prior to analysis) within budget/timelines and per regulations/standards, Genmab SOPs, and ICH-GCP.
- Ensure oversight of DM vendors and deliverables; ensure appropriate stakeholder involvement and communication.
- Provide trial/data management input to clinical development plans; serve as Clinical Data Management representative in operational committees/fora.
- Lead/participate in working groups (e.g., data protection regulation, biomarker group setup, ePRO, IRT) and drive data management alignment meetings.
- Provide oversight of DM CRO and key activities from setup to database lock (SOW, budget, KPIs; eCRF design, UAT, go-live approval; DMP/DVP; data cleaning; transfer specs; query trend evaluation; archiving/data transfer; coding listings approval).
- Review/provide input to protocols/amendments, protocol deviations classification, randomization/stratification, and TFLs; ensure blinding procedures where applicable.
- Support timely dashboards (if applicable), audit/inspection readiness and response, and escalation as needed.
- Lead/contribute to knowledge sharing, SOP/process optimization, cross-functional working groups/projects, and IT tools/technology implementation.
Requirements:
- Bachelor’s degree in science or related area (or equivalent).
- 10+ years’ clinical data management experience in biotech/pharma with hands-on DM across all aspects and phases of clinical trials.
- Significant leadership experience; advanced use of data management systems; advanced DM processes/tools/methodologies/documentation and DM strategy.
- Experience with CDISC (SDTM) and clinical trial data collection requirements.
- Understanding of protocol development-to-analysis data lifecycle relationships.
- Knowledge of GCPs, SOPs, regulatory requirements, and data management best practices.
- Experience supporting early and late-stage submissions per local/regulatory requirements.
- Experience working in and leading cross-functional teams.
Competencies (must have): Project management; planning/organization; clinical trial conduct (ICH-GCP); team leadership; clear scientific communication; problem solving/decision making; quality mindset; document management; process development; proactive/accountable; analytical ability to interpret/present clinical data; IT skills.
Benefits (U.S. first-year regular full-time employees): 401(k) 100% match on first 6%; two medical plan options (incl. HDHP/HSA), dental, vision; voluntary plans; paid vacation/sick/holidays and 12 weeks paid parental leave; backup care and family support; commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Application instructions: Not specified in the provided text.
- As “Data Manager,” operationally responsible for planning, start-up, conduct, and closure of clinical trials from final synopsis/CTT assignment.
- Deliver core clinical data management deliverables (e.g., EDC setup, data collection, clinical database validation prior to analysis) within budget/timelines and per regulations/standards, Genmab SOPs, and ICH-GCP.
- Ensure oversight of DM vendors and deliverables; ensure appropriate stakeholder involvement and communication.
- Provide trial/data management input to clinical development plans; serve as Clinical Data Management representative in operational committees/fora.
- Lead/participate in working groups (e.g., data protection regulation, biomarker group setup, ePRO, IRT) and drive data management alignment meetings.
- Provide oversight of DM CRO and key activities from setup to database lock (SOW, budget, KPIs; eCRF design, UAT, go-live approval; DMP/DVP; data cleaning; transfer specs; query trend evaluation; archiving/data transfer; coding listings approval).
- Review/provide input to protocols/amendments, protocol deviations classification, randomization/stratification, and TFLs; ensure blinding procedures where applicable.
- Support timely dashboards (if applicable), audit/inspection readiness and response, and escalation as needed.
- Lead/contribute to knowledge sharing, SOP/process optimization, cross-functional working groups/projects, and IT tools/technology implementation.
Requirements:
- Bachelor’s degree in science or related area (or equivalent).
- 10+ years’ clinical data management experience in biotech/pharma with hands-on DM across all aspects and phases of clinical trials.
- Significant leadership experience; advanced use of data management systems; advanced DM processes/tools/methodologies/documentation and DM strategy.
- Experience with CDISC (SDTM) and clinical trial data collection requirements.
- Understanding of protocol development-to-analysis data lifecycle relationships.
- Knowledge of GCPs, SOPs, regulatory requirements, and data management best practices.
- Experience supporting early and late-stage submissions per local/regulatory requirements.
- Experience working in and leading cross-functional teams.
Competencies (must have): Project management; planning/organization; clinical trial conduct (ICH-GCP); team leadership; clear scientific communication; problem solving/decision making; quality mindset; document management; process development; proactive/accountable; analytical ability to interpret/present clinical data; IT skills.
Benefits (U.S. first-year regular full-time employees): 401(k) 100% match on first 6%; two medical plan options (incl. HDHP/HSA), dental, vision; voluntary plans; paid vacation/sick/holidays and 12 weeks paid parental leave; backup care and family support; commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Application instructions: Not specified in the provided text.