Senior Clinical Trial Manager
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Responsibilities
- Lead the operational planning, setup, and execution of global clinical trials, ensuring delivery on time, and in compliance with regulatory and quality standards.
- Oversee trial documentation and systems, ensuring accuracy, completeness, and continuous inspection readiness.
- Drive site feasibility, selection, and activation strategies in collaboration with CROs and internal stakeholders.
- Manage and oversee CROs and other service providers, ensuring high-quality deliverables, adherence to timelines, and effective collaboration.
- Proactively identify, assess, and mitigate operational risks using risk-based quality management approaches.
- Oversee protocol deviations, issue management, and ensure appropriate escalation and resolution of trial-level challenges.
- Monitor trial performance and data quality, leveraging key metrics to drive decision-making and continuous improvement.
- Act as a key cross-functional leader, fostering strong collaboration across internal teams, vendors, and investigators.
Requirements
- Bachelor's degree in life sciences or related field (Master's degree preferred).
- 8+ years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
- Solid understanding of ICH/GCP regulations and the clinical drug development lifecycle.
- Proven experience managing global, multi-center trials and working in a complex, matrixed organization.
- Strong project management and service provider oversight skills.
- Excellent communication, collaboration, and interpersonal skills.
- Oncology and/or therapeutic area-specific experience is highly desirable.
- Ability to lead without authority and mentor others in a cross-functional environment.
Benefits
Additional Information
At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain 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. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us!
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