Director, Data Quality & Process, Clinical Data

Salary: $189,200 - 283,800 per year Requirements:

• We require a bachelors degree in a scientific, technical, or health-related discipline; an advanced degree such as an MS or PhD is preferred.
• We expect at least 15 years of experience in clinical research or clinical data management.
• We require a minimum of 5 years in strategic leadership within Clinical Data Management or External Data Management.
• We look for extensive experience managing external clinical data sources, including laboratories, imaging, eCOA, IRT, biomarkers, wearables, and other third-party data.
• We need prior experience leading global CRO and vendor oversight.
• We require experience developing clinical data management standards, processes, and governance frameworks.
• We expect experience supporting regulatory inspections and submission readiness, with a strong understanding of end-to-end trial conduct.
• We value strong project management capability, strategic planning skills, and portfolio-level thinking.
• We look for an operational excellence mindset with a focus on process improvement.
• We require strong cross-functional alignment and communication skills.
• We value problem-solving ability, critical thinking, and sound decision-making.
• We expect knowledge of EDC systems, ICH-GCP, GCDMP, and relevant regulatory expectations.
• Oncology experience is strongly preferred.

• We serve as the functional lead for External Data Quality and Process across the clinical development portfolio.
• We define and execute the strategic roadmap for external data quality, operational excellence, and process governance.
• We promote portfolio consistency through standardized processes, governance frameworks, metrics, and best practices.
• We lead cross-functional initiatives that support organizational growth, scalability, and operational excellence.
• We advise senior leadership on external data strategy, operational risks, and quality enhancements.
• We foster a culture of continuous improvement and operational excellence across Development Operations.
• We develop, implement, and govern external data management processes, standards, SOPs, work instructions, and guidance materials.
• We ensure consistent application of external data standards across studies and vendors.
• We drive improvements in data quality, external data flow efficiency, risk reduction, and inspection readiness.
• We lead lessons learned activities and turn findings into lasting process improvements.
• We assess emerging technologies, automation, AI solutions, and industry practices to improve efficiency.
• We provide strategic oversight of CROs and external data vendors supporting clinical trials.
• We create vendor oversight models, KPIs, KQIs, governance processes, and performance metrics.
• We lead vendor qualification, RFP reviews, bid defenses, and statement of work assessments.
• We partner with vendors to improve quality, operational consistency, issue resolution, and innovation.
• We ensure vendor practices align with our standards and regulatory expectations.
• We escalate major operational risks and help resolve them through governance forums when needed.
• We build strong partnerships across Clinical Data Management, Clinical Operations, Medical, Biomarker Operations, Clinical Programming, Biostatistics, Regulatory, Quality Assurance, and Development Operations.
• We lead cross-functional governance meetings for external data strategy and execution.
• We align business processes, technology solutions, and operational goals.
• We contribute subject matter expertise in external data management and operational risk to influence decisions.
• We lead inspection-readiness strategy for External Data Management.
• We ensure external data processes comply with ICH-GCP, GCDMP, regulatory guidance, and our quality standards.
• We support inspections, audits, root cause analyses, CAPAs, and continuous quality improvement efforts.
• We monitor quality trends across the portfolio and implement proactive mitigation plans.
• We develop onboarding programs and role-based training across the portfolio.
• We create functional playbooks, guidance documents, templates, and standards libraries.
• We encourage knowledge sharing and consistency across internal teams and external partners.
• We mentor team members and help develop future leaders within External Data Management.
• We cultivate a collaborative environment centered on innovation, accountability, and continuous learning.
• We coordinate alignment meetings within the data management group to ensure consistent practices across trials and vendor-partner work.
• We represent Clinical Data Management on cross-functional governance committees.
• We represent our company in industry initiatives and external working groups as appropriate.
• We stay current on industry trends, technologies, regulatory expectations, and best practices.
• We support departmental objectives and strategic initiatives as assigned.
• We act as a subject matter expert for External Data Quality Management.

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We are Genmab, an international biotechnology company dedicated to improving patients lives through innovative and differentiated antibody therapeutics. Founded in 1999 and headquartered in Copenhagen, Denmark, we have a global presence across North America, Europe, and Asia Pacific. Our team is compassionate, candid, purposeful, and science-driven, and we are building a workplace where authentic contributions are valued. This Director role sits within our External Data Management leadership structure and offers the opportunity to shape quality, governance, vendor oversight, and operational excellence across our global clinical development portfolio. We also offer a competitive U.S. compensation range, with additional bonus and long-term incentive eligibility for certain roles, alongside a strong benefits package that includes retirement savings matching, medical, dental, and vision coverage, paid time off, parental leave, wellness resources, commuter support, tuition reimbursement, and more.

last updated 32 week of 2026