At Genmab, we are dedicated to building extraordinary futures by developing antibody products and groundbreaking medicines. We strive to create a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families, and employees.
Requirements
- Develop and manage operational plans, charters, and manuals to support trial execution
- Coordinate the development of and manage updates of the Trial Oversight Plan
- Review of the Investigator's Brochure from DevOps perspective
- Review of the Clinical Trial Application submission package
- Act as a key liaison between internal stakeholders and CROs to oversee sponsor oversight visits and ensure quality and compliance across all activities
- Collaborate with the CRO and/or internal functions to oversee site selection based on feasibility assessments
- Monitor and manage vendor deliverables across trial operations
- Ensure ongoing accuracy and completeness of the eTMF
- Drive the Operational Data Base review for the trial
- Engage in Risk Based Quality Management activities to enhance data quality and monitoring practices
- Maintain relevant sections in Clinical Trial Management Systems and Tools
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
