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Sponsor Oversight Lead

Job

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.

The Role

The Clinical Trial Operations area of Genmab is growing and looking for several Sponsor Oversight Leads (SOL) to join the team in DK, US, or NL.

As Sponsor Oversight Lead at Genmab, you will be responsible for the planning, conducting, and coordination of trial oversight activities together with internal and external stakeholders to ensure quality and integrity of the data. The SOL works closely together with the Clinical Trial Managers with the oversight activities across Genmab clinical trials.

The new Sponsor Oversight Lead will join a highly experienced team and be reporting to the Associate Director, Team Lead, Clinical Oversight.

Responsibilities

The responsibilities of the role will include, but are not limited to:

  • Develop the Sponsor oversight strategy together with the trial team

  • Plan and perform Sponsor oversight visits and booster/site oversight visits

  • Accountable for development of trial oversight plan and ensure regular review of the trial team’s oversight activities

  • Feasibility review

  • Support Regulatory Green Light activities

  • Drive eTMF spot-check for the trial team and in collaboration with the CTM and CTA

  • Oversight of CRO training records, monitoring report review etc.

  • Attend and coordinate CRA training activities with CRO

  • Support during inspections and audits

Requirements

  • It is expected that you have a minimum 2 years' experience with monitoring and/or co-monitoring of clinical trials (Phase I experience preferred)

  • Preferably 3 years’ experience as Trial Manager or Lead CRA from a CRO and/or pharmaceutical company

  • Extensive knowledge of working with trial oversight activities is required

Moreover, you meet the following personal requirements:

  • You are structured and process oriented

  • You have a quality mindset and able to prioritize your work in a fast paced and changing environment

  • You have good interpersonal and communication skills during interactions with investigators and other external and internal stakeholders

  • You are able to work independently as well as within global teams

  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab

Learn more and apply today at: Sponsor Oversight Lead (myworkdayjobs.com)

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.

Location Utrecht
Sponsor Oversight Lead

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