Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. - Regional Sponsor Oversight Lead
The Role The Regional Sponsor Oversight Lead (RSOL) will drive on-site and remote Oversight activities across all trials/countries/sites within a region to support trial teams. The regional SOL will work closely together with the Clinical CRO in the countries/regions where the employee is performing sponsor oversight to get in-depth local knowledge on local requirements to support the efficient conduct of Genmab clinical trials.
Responsibilities The responsibilities of the role will include, but are not limited to:
Attend PSSV and SIV to support trial start-up activities, as applicable;
Support on-site and remote oversight activities regionally;
Support audit and site inspection activities in close collaboration with the Genmab trial teams and the QA department;
Support development of mitigation plans and give input to the Trial Specific Oversight plan;
Review of monitoring reports;
Plan and perform Sponsor oversight visits and booster/site oversight visits;
Support eTMF review;
Support other Genmab SOL activities such as training of clinical CRO in accordance with the trial Oversight plan across trials;
Assist/give input in trials teams to the trial "issue log".
Requirements It is expected that you have a minimum of 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.
At Genmab, we pride ourselves on our unique culture. We are committed to making a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee's role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team.
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. Genmab employees work with determination, challenge the status quo, and cultivate a growth mindset in everything we do.
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