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Sponsor Oversight Lead

Genmab



Sponsor Oversight Lead

Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

The Role

The Clinical Trial Operations area of Genmab is growing and looking for a Sponsor Oversight Lead (SOL) to join the team in Copenhagen.

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 across Genmab. 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 in Copenhagen and be reporting to the Director, Team Lead, Trial Management.

Responsibilities

The responsibilities of the role will include, but is 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 5+ 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

Application and further information:

If you would like additional information about this position, please contact Hanne Beirholm, Beirholm Search. Tel. +4529440080 /mail: kontakt@beirholmsearch.dk

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.

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Genmab - hurtigt overblik


Genmab
Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has three approved products in collaboration, a broad clinical and pre-clinical product pipeline and four proprietary next generation antibody technologies.

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Kalvebod Brygge 43
1560 København V
Logo: Genmab
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