Genmab

Associate Director, Standards and Systems, Clinical Data Management

Genmab

full-time

Posted on:

Location Type: Remote

Location: Denmark

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

About the role

  • 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
  • Lead the design and maintenance of standard CRFs, metadata libraries, and configuration templates within EDC platforms
  • 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
  • Provide oversight and expert guidance on study build strategy and configuration

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
  • Proven expertise in the development, deployment, and governance of CRFs, edit checks, visit structures, and controlled terminology
  • Experience in managing and mentoring staff within a technical function
  • Strong project leadership and systems oversight skills
  • Knowledge of clinical trial data management systems and tools
Benefits
  • Health insurance
  • Paid time off
  • Flexible work arrangements
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
data managementclinical data standardsCRF developmentmetadata librariesEDC platformschange control processesversion managementstudy build strategyedit checkscontrolled terminology
Soft skills
strategic leadershipsubject matter expertisecollaborationproject leadershipmentoringoversight skills