Associate Director, Clinical Data Manager

Genmab • Princeton, FL

2d

About The Position

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 An Associate Director, Data Management can hold two roles; a “Lead Data Manager” role and/or a Data Manager role, referred to as “Data Manager”. As “Data Manager” the employee is operationally responsible for the planning, start-up, conduct and closure of clinical trials from the point in time where a final synopsis and/or a Clinical Trial Team (CTT) is assigned. In the “Lead Data Manager” role, the employee may act as a Data Management Lead and be responsible for the oversight and consistency across the trials within one or more development projects. The DM Lead will provide asset-level DM expertise, ensure project level standards are established and followed, and ensure consistency of DM processes across all trials within the asset. The DM Lead will provide support to trial Data Managers within the asset to ensure consistency of data management practices across the asset. When applicable, the DM Lead will provide data management expertise to the Clinical Development Team and to co-sponsor collaborations/external partners. The DM Lead will participate in and drive implementation of lessons learned and of new/innovative procedures to ensure high standards/improvement of data management related processes/systems, which may involve cross departmental stakeholders.

Requirements

• 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

Nice To Haves

• Experience in oncology preferred.

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees