Genmab · 1 day ago
Associate Director, Clinical Data Manager
Princeton, NJ
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$157K/yr - $236K/yr
10+ years expGenmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. The Associate Director, Clinical Data Manager will be responsible for overseeing clinical trials and ensuring compliance with data management processes, while also providing leadership and support to the data management team.
BiotechnologyHealth CareManufacturingMedical
Responsibilities
Give input to the clinical development plans through the Development Operations representatives of the CDT ensuring that data management input/knowledge that could impact the setup and conduct of trials is proactively considered and discussed upon development of the operational strategy of the trials
Serve as Clinical Data Management representative in Operational Committee/fora with the partners, DM vendors or other vendors handling data
Participate in working groups e.g. Data protection regulation, setup of data in biomarker group, ePRO, IRT etc
Drive alignment meetings within the data management group
Attend various working groups where data management expertise is required
Provide oversight of DM CRO including: Statement of Work; budget; KPIs; and other DM CRO trial data management activities from set up to database lock
Perform vendor oversight related to key deliverables e.g. eCRF design development, review of the eCRF completion guide, UAT, approve eCRF go live, Data management plan, Data validation plan, data cleaning activities, ensuring data transfer specifications with all external data providers e.g. lab, ECG, ePRO etc., evaluate trends in DM raised queries, ensuring final transfer of data for archiving including development of site CDs, ensuring coding listings are approved etc
Proactively participate and represent data management in the CTT and provide oversight on progression and status of related activities
Proactively discuss risks management related to data management activities in relation to trial conduct
Review and provide input to protocol and amendment development
Give input to protocol deviations classifications, randomization and stratification plans, tables, figures and listings etc
Ensure procedures for blinding are in place where applicable
Support timely delivery of data management deliverables in accordance with Genmab SOP and ICH/GCP
Attend trial and investigator/monitor meetings as needed
Participate in definition, review and approval of data packages for Data Monitoring Committee’s, if applicable
Review and approve any corrections and updates of data packages, if applicable
Support timely development, update and maintenance of dashboards, if applicable
Support vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Data management, ePRO and IRT related activities and define/specify scope of work for functional tasks
Review scope of work in a given trial in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)
Attend operational committee meetings, as applicable
Ensure compliance with relevant regulations, Genmab SOPs and ICH GCP
Ensure escalations are made as appropriate to secure proper progress and quality of the trial
Ensure compliance with Genmab Code of Business Ethics
Ensure that the trial oversight activities are conducted in accordance with the trial oversight plan, e.g. ongoing review of the trial eTMF, support risk assessment analysis in the CTTs, CTT data quality review activities etc
Participate in audits and inspections as applicable
Ensure timely response to audit/inspection including carrying out a comprehensive root cause analysis and share learnings across trials as applicable
Support project submission activities e.g. providing listings and documentation
Lead/contribute with knowledge sharing within the department
Follow scientific, process and technical progress within the field of data management in drug development and advise of new methodologies that may support innovation and improve efficiencies
Contribute on processes optimizations and SOP revisions
Lead cross-functional working groups/projects/task forces or new IT tools & technology implementation
Qualification
Required
Bachelor's degree in science or related area (or equivalent)
Minimum of 10+ years of experience in clinical data management
Strong understanding of end‑to‑end trial conduct
Strong Project Management capability
Strategic planning and portfolio thinking
Operational excellence and process improvement mindset
Cross‑functional alignment and communication
Vendor oversight and partnership management
Problem solving, critical thinking and decision making
Knowledge of EDC systems, ICH‑GCP, GDMP, and regulatory expectations
Preferred
Experience in oncology preferred
Benefits
401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Company
Genmab
Genmab is a biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer.
1001-5000 employees
H1B Sponsorship
Genmab has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (10)
2023 (6)
2022 (3)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$11.7BKey Investors
Morgan Stanley Senior FundingGlaxoSmithKlineIndex Ventures
2025-11-18Post Ipo Debt· $6B
2025-09-29Post Ipo Debt· $5.5B
2010-07-01Post Ipo Equity· $134M
Leadership Team
Anthony Pagano
Chief Financial Officer
Anthony Mancini
EVP & Chief Operating Officer
Recent News
pharmaphorum
2026-01-03
Clinical Trials Arena
2026-01-03
2025-12-31
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