Senior Clinical Data Manager

Role Overview

• 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.

Tech Stack

• Google Cloud Platform

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