Remote Position
[Remote] Director, Data Quality and Process, External Data Clinical Data Management
🌍 Remote · United States
💼 Full-time
Note: The job is a remote job and is open to candidates in USA. Genmab is an international biotechnology company developing innovative antibody therapeutics for cancer and other serious diseases. The Director will lead external clinical data quality, process standardization, operational excellence, vendor oversight, governance, and inspection readiness across the global clinical development portfolio.
Responsibilities
- Serve as the functional leader for External Data Quality and Process across the clinical development portfolio
- Develop and execute the strategic roadmap for external data quality, operational excellence, and process governance
- Drive portfolio consistency through standardized processes, governance models, metrics, and best practices
- Lead cross-functional initiatives supporting organizational growth, scalability, and operational excellence
- Provide strategic recommendations to senior leadership regarding external data strategy, operational risks, and quality improvements
- Champion a culture of continuous improvement and operational excellence across Development Operations
- Lead development, implementation, and governance of external data management processes, standards, SOPs, work instructions, and guidance documents
- Ensure consistent implementation of external data standards across all studies and vendors
- Drive initiatives that improve data quality, streamline external data flows, reduce operational risk, and enhance inspection readiness
- Lead lessons learned activities and translate findings into sustainable process improvements
- Evaluate emerging technologies, automation, AI solutions, and industry best practices to improve operational efficiency
- Provide strategic oversight of CROs and external data vendors supporting clinical trials
- Develop vendor oversight models, KPIs, KQIs, governance processes, and performance metrics
- Lead vendor qualification activities, RFP evaluations, bid defenses, and review of Statements of Work
- Partner with vendors to improve quality, operational consistency, issue resolution, and innovation
- Ensure vendor processes align with Genmab standards and regulatory expectations
- Escalate significant operational risks and drive resolution through governance committees when appropriate
- Build strong partnerships across Clinical Data Management, Clinical Operations, Medical, Biomarker Operations, Clinical Programming, Biostatistics, Regulatory, Quality Assurance, and Development Operations
- Lead cross-functional governance meetings supporting external data strategy and execution
- Ensure alignment between business processes, technology solutions, and operational objectives
- Influence organizational decision-making by providing expertise in external data management and operational risk
- Lead inspection readiness strategy for External Data Management
- Ensure external data processes comply with ICH-GCP, GCDMP, regulatory guidance, and Genmab quality standards
- Support regulatory inspections, audits, root cause analyses, CAPAs, and continuous quality improvement activities
- Monitor portfolio quality trends and implement proactive mitigation strategies
- Develop portfolio-wide onboarding programs and role-based training
- Lead development of functional playbooks, guidance documents, templates, and standards libraries
- Promote knowledge sharing and consistency across internal teams and external partners
- Mentor team members and contribute to development of future leaders within External Data Management
- Foster a collaborative environment focused on innovation, accountability, and continuous learning
- Drive 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
- Represent Clinical Data Management on cross-functional governance committees
- Represent Genmab on industry initiatives and external working groups as appropriate
- Maintain awareness of evolving industry trends, technologies, regulatory expectations, and best practices
- Support departmental objectives and strategic initiatives as assigned
- Serve as Subject Matter Expert for External Data Quality Management
Skills
- Bachelor's degree in a scientific, technical, or health-related field
- Minimum 15+ years of clinical research or clinical data management experience
- Minimum 5 years in strategic leadership within Clinical Data Management or External Data Management
- Extensive experience managing external clinical data including laboratories, imaging, eCOA, IRT, biomarkers, wearables, and other third-party data sources
- Experience leading global CRO and vendor oversight<