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Associate Director, Clinical Data Management
Location
Belgium
Posted
157 days ago
Salary
0
Seniority
Senior
Job Description
Associate Director, Clinical Data Management
Genmab
• Drive the implementation of standardized and consistent data management activities across the portfolio • Provide strategic leadership and subject matter expertise in the development, implementation, and governance of CRF standards and data management systems • Act as a subject matter expert (SME) for clinical data standards, including eCRF design, edit checks, visit structures, and controlled terminology • Lead the design and maintenance of standard CRFs, metadata libraries, and configuration templates within EDC platforms (e.g., Medidata Rave) • Collaborate cross-functionally with stakeholders such as Data Management, Biostatistics, Programming, Trial Strategy & Delivery (TSD), and Medical • Oversee change control processes, version management, and lifecycle governance of CRF components within the Global Library • Provide oversight and expert guidance on study build strategy and configuration • Serve as a senior escalation point for issues related to form design, standards deviations, or system configuration inconsistencies • Mentor and support team members, including Managers and Senior Managers
Job Requirements
- Bachelor's degree in science or related area (or equivalent)
- 10+ years of Industry Related Experience in clinical data standards, electronic data capture (EDC) systems, clinical data management, or related functions within the pharmaceutical, biotechnology, or CRO industry
- Foundational knowledge of data standards and metadata management, including familiarity with industry frameworks such as CDISC (CDASH, SDTM) and controlled terminology
- Proven expertise in the development, deployment, and governance of CRFs, edit checks, visit structures, and controlled terminology, particularly within oncology trials
- Experience in managing and mentoring staff within a technical function; people management or functional leadership experience strongly preferred
- Strong project leadership and systems oversight skills
- Skilled in identifying risks, resolving form and system-level issues, and making sound decisions in a complex, matrixed environment
- Experience with clinical trials and the drug development process
- Significant experience leading data management activities in clinical trials
- Advanced use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation
- Advanced understanding of DM strategy
- Experience with CDISC (SDTM); as well as data collection requirements in clinical trials
- Experience working on early and late-stage submissions as per local/regulatory requirements
- Experience working in and leading cross-functional teams
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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