Associate Director, External Data Quality Manager

The RoleAssociate Director, External Data Quality Management, is a strategic leadership role supporting high‐quality execution of Genmab's clinical trial portfolio. This individual is accountable for driving the strategy, quality, and integrity of external data across the clinical programs.The Associate Director will guide cross‐functional teams, oversee external data quality and vendor performance, and champion harmonized operational approaches that strengthen trial delivery, inspection readiness, and decision making.Responsibilities1. Portfolio and Strategic LeadershipServe as a portfolio‐level lead for external data quality and clinical data‐related operational strategy.Drive consistency of processes, quality expectations, and documentation across studies, assets, and vendors.Solve complex operational issues by gathering detailed inputs, synthesizing technical and business considerations, formulating data‐driven recommendations, securing cross‐functional alignment, and leading effective implementation.Influence portfolio‐level decision making by providing strategic insights on risks, timelines, and data‐dependent operational impacts.Contribute to asset‐level planning, governance forums, and clinical development strategy discussions.2. External Data Quality OversightOversee portfolio‐level strategy for acquisition, integration, and quality oversight of third‐party data (e.g., central/local labs, eCOA, imaging, biomarkers).Provide expert review of protocol requirements, vendor specifications, and operational data flows.Lead proactive data quality surveillance and escalation management.3. Cross‐Functional CollaborationCollaborate with Trial Management, Medical, Biomarker Operations, Clinical Programming, Biostatistics, and Medical Writing to ensure aligned execution and issue resolution.Ensure operational readiness and cross‐functional understanding of external data processes, timelines, and deliverables.Participate in governance forums and asset‐level data planning initiatives.4. Process Excellence and StandardizationDrive continuous improvement initiatives that enhance efficiency, consistency, and inspection readiness across Clinical Operations and Clinical Data Management.Lead the development, implementation, and governance of standardized processes, playbooks, RACI models, and best practices.Identify operational bottlenecks and deliver scalable solutions at portfolio level.5. Vendor and Partnership OversightProvide strategic oversight of external vendors handling clinical data; focus on operational performance, quality compliance, and cross‐trial consistency.Represent External Data Quality Management on Operational Committees with CROs or external data vendors.6. Regulatory and Submission SupportContribute to regulatory submission strategy, ensuring external data and associated processes meet inspection and documentation requirements.Provide asset‐level oversight of data‐related deliverables for submissions.Additional ResponsibilitiesDrive alignment meetings within the data management group to ensure consistency of data management practices across trials within an asset and/or within the trials conducted by a DM vendor/partner.Contribute to the development of best practices/SOPs within Genmab Clinical Data Management, aligned with industry and regulatory best practices.Provide subject matter expertise to various task forces and initiatives.Act as Portfolio Asset External Data Quality Management Lead as required.Mentor and develop new team members.QualificationsBachelor's degree in a scientific, technical, or health‐related field; advanced degree (MS, PhD) preferred.Minimum of 10 years of experience in clinical operations, clinical data management, or other related clinical research experience with at least 3‐5 years in oversight and leadership roles.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.Experience in oncology preferred.SalaryFor US‐based candidates, the proposed salary band for this position is $157,360.00 – $236,040.00. The actual salary offer will consider factors including skills, qualifications, experience and location. Additional compensation may be available such as discretionary bonuses and long‐term incentives.Benefits401(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.About YouGenuinely passionate about our purpose.Brings precision and excellence to all that you do.Believes in our rooted‐in‐science approach to problem‐solving.Is a generous collaborator who can work in teams with a broad spectrum of backgrounds.Pride in enabling the best work of others on the team.Can grapple with the unknown and be innovative.Has experience working in a fast‐growing, dynamic company (or a strong desire to).Works hard and is not afraid to have a little fun while doing so.LocationsGenmab offers an agile working environment that maximizes employee work‐life balance. Offices are open, community‐based, and can be visited or work remotely. We thrive on connecting with each other to innovate.#J-18808-Ljbffr