Company Name: Genmab

Job Details: Be an Early Applicant Hiring Remotely in United States Remote 157K-236K Annually Expert/Leader

Job Url: https://builtin.com/job/associate-director-external-data-quality-manager/6360800

Job Description: 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 RoleThe Associate Director, External Data Quality Management, is a strategic leadership role within Clinical Data Management. This individual is accountable for driving the strategy, quality, and integrity of external data across the clinical trial portfolio. This role serves as a Subject Matter Expert (SME) in protocol quality, central and local lab data, and protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide oversight of third-party data vendors, and promote best practices and process optimization to support business continuity and data consistency across programs as well as provide project-specific work as needed.ResponsibilitiesStrategic and Operational LeadershipDefine and implement strategy for acquisition, integration, and quality oversight of third-party external data (e.g., labs, eCOA, biomarkers, imaging).Serve as SME in protocol quality, lab data integrity (central and local), and management of protocol deviations across studies.Provide strategic guidance on data workflows and compliance across the clinical portfolio.Data Quality and ReconciliationOversee and guide the execution of external data reconciliation across studies.Ensure consistency and completeness of data through proactive data quality reviews and analytics.Collaborate with clinical and data management teams to interpret discrepancies and resolve data issues.Cross-functional CollaborationCollaborate with Trial Management, Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with protocol and submission goals.Participate in governance forums and asset-level data planning initiatives.Subject Matter ExpertiseProvide protocol-level consultation and design input to ensure external data requirements are aligned with clinical and scientific objectives.Provide SME-level training on lab data management and protocol deviation handling to internal teams and vendors.Support cross-study harmonization of data quality practices.Process Excellence and Standards DevelopmentDrive the development and implementation of SOPs, best practices, and standards for external data workflows.Lead or contribute to initiatives that improve operational efficiency, inspection readiness, and regulatory compliance.Act as a Data Standards or Clinical Systems Lead as needed.Regulatory and Submission SupportContribute to submission readiness activities and ensure external data is appropriately documented for audits and inspections.Ensure adherence to GCP, GDMP, ICH, and global regulatory requirements.RequirementsBachelor’s degree in a scientific, technical, or health-related field; advanced degree (MS, PhD) preferred.Minimum of 10 years of experience in clinical data management, clinical operations, or other related clinical research experience with at least 3–5 years in data oversight and leadership roles.Experience with external vendor management a plus.Proven expertise in protocol design, data quality management, and protocol deviation oversight.Strong knowledge of EDC systems, data reconciliation practices, and industry data standards (e.g., CDISC/CDASH).Excellent cross-functional communication and project management skills.Experience supporting regulatory filings and inspection readiness preferred.Experience in oncology preferred.For US based candidates, the proposed salary band for this position is as follows:$157,120.00---$235,680.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:401(k) Plan: 100% match on the first 6% of contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans: Critical illness, accident, and hospital indemnity insuranceTime Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leaveSupport Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About YouYou are genuinely passionate about our purposeYou bring precision and excellence to all that you doYou believe in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with a broad spectrum of backgroundsYou take pride in enabling the best work of others on the teamYou can grapple with the unknown and be innovativeYou have experience working in a fast-growing, dynamic company (or a strong desire to)You work hard and are not afraid to have a little fun while you do so!LocationsGenmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.About GenmabGenmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.