Clinical Trial Planning Manager
2 weeks ago
We are seeking a highly skilled Clinical Trial Planning Manager to join our Development Program Management team at Genmab. As a key member of our global Portfolio & Project Management department, you will play a pivotal role in advancing transformative therapies to patients.
Key Responsibilities- Develop and execute comprehensive clinical trial execution plans for assigned studies (Phase I-IV), utilizing project management tools like Microsoft Project.
- Collaborate with Global Clinical Trial Managers to construct and monitor clinical trial execution plans, ensuring alignment with our Global Development Operations (Dev Ops) colleagues.
- Facilitate the crafting of clinical trial plans in sync with defined program timelines, ensuring cross-functional input and verification.
- Engage in scenario planning to aid the trial management team in outlining the strategy for trial execution.
- Monitor the overall trial health and the delivery of clinical trial milestones, identifying gaps and risks in the trial plans and collaborating to prepare solutions.
- Provide trial-specific timelines and/or dashboards to trial management teams to spotlight past due and upcoming tasks and milestones.
- Conduct critical path analysis to drive the optimization of trial execution and assess risks to milestone delivery.
- A minimum of a Bachelor's degree in a scientific or healthcare domain.
- Minimum of 4 years of experience in a project or clinical trial management, with at least 3 years in the pharmaceutical or healthcare industry.
- High-level comprehension of the end-to-end clinical trial planning and execution.
- Highly proficient in MS Project and MS Office Suite.
- Familiarity in the use of Clinical Trial Management System and Portfolio Management systems like Planisware is a plus for milestone and driver tracking.
- Strong analytical acumen and confident communication ability to identify and report risks.
- The ability to work independently with a high degree of accountability as well as work effectively in a collaborative team environment.
- Demonstrated project management skills with a working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Ability to negotiate and liaise with colleagues professionally and present to staff at all levels.
- Financial acumen and ability to contribute to budget management.
Genmab is a dynamic and innovative company committed to building extraordinary futures together. We develop antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science.
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