Operationally responsible for the planning, start-up, conduct and closure of clinical trials
Provide oversight of the DM CRO and ensure performance against key indicators
Support/training colleagues in handling data management related processes/issues and mentoring
Participate in and drive implementation of lessons learned and new procedures to ensure high standards/improvement
Ensure compliance with relevant regulations, Genmab SOPs and ICH GCP
Perform vendor oversight related to key deliverables
Give input to the clinical development plans through the Development Operations representatives
Support vendor qualification in terms of Data management, ePRO and IRT related activities

Requirements

Bachelor's degree in science or related area (or equivalent)
Minimum of 8 years of experience in clinical data management
Strong understanding of end-to-end trial conduct
Strong Project Management capability
Strategic planning and portfolio thinking
Operational excellence and process improvement mindset
Cross-functional alignment and communication
Vendor oversight and partnership management
Problem solving, critical thinking and decision making
Knowledge of EDC systems, ICH-GCP, GDMP, and regulatory expectations
Experience in oncology preferred.

Benefits

401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical data managementend-to-end trial conductproject managementstrategic planningprocess improvementvendor oversightproblem solvingcritical thinkingdecision makingknowledge of EDC systems

Soft Skills

operational excellencecross-functional alignmentcommunicationmentoring

Certifications

Bachelor's degree in scienceICH GCP