(Senior) Manager, Clinical Trial Planning

3 maanden geleden

Utrecht, Nederland Genmab Voltijd

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

As a Sr. Manager Clinical Trial Planner, you will join our Development Program Management team, part of our global Portfolio & Project Management (PPM) department. This is a newly created role due to organizational growth. Your expertise will be central in managing clinical trials from initiation to final reporting, ensuring alignment with our Global Development Operations (Dev Ops) colleagues, thus playing a pivotal role in advancing transformative therapies to patients. You will report directly to the Senior Director, Development Program Management.

Responsibilities:

  • Clinical Trial Planners partner with Global Clinical Trial Managers to construct and monitor clinical trial execution plans for assigned studies (Phase I-IV), utilizing project management tools like Microsoft Project.

  • The Clinical Trial Planner is entrusted with the responsibility to deliver for designated trials or programs:

    • Comprehensive and integrated clinical trial execution plans (Phase I-IV) for Dev Ops commencing with project governance endorsement and steered through Clinical Study Report finalization.

    • Facilitate the crafting of clinical trial plans in sync with defined program timelines, ensuring cross-functional input and verification.

    • Trial and cross-asset/indication critical path analyses to bolster optimization of trial planning, country allocation & feasibility, and scrutinizing risks to trial delivery.

  • Engage in scenario planning to aid the trial management team in outlining the strategy for trial execution.

  • Collaborate with the Clinical Trial Teams to monitor the overall trial health and the delivery of clinical trial milestones.

  • Identify gaps and risks in the trial plans and collaborate to prepare solutions aimed at augmenting efficiency and curtailing timeline overruns.

  • Provide trial-specific timelines and/or dashboards to trial management teams to spotlight past due and upcoming tasks and milestones. Use of visualization tools and software.

  • Provide trial or project status reports to key stakeholders as needed or in line with established processes and best practices.

  • Conduct critical path analysis to drive the optimization of trial execution and assess risks to milestone delivery.

  • Employ timeline tools and planning strategies to enable data-driven decisions in support of trial execution and necessary change management process.

Requirements:

  • A minimum of a Bachelor’s degree; preferred to be 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.

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to grapple with the unknown and be innovative
  • You have experience working in a fast-growing, dynamic company (or a strong desire to)
  • You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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