Sponsor Oversight Lead

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

Job Description

Sponsor Oversight Lead

The Role

 

The Clinical Trial Operations area of Genmab is growing and looking for several Sponsor Oversight Lead/Managers (SOL/SOM) 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 

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 environment, with an aim to make a difference in the lives of people with cancer.



At Genmab, we pride ourselves on our unique culture. We are committed to make 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.

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information.

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 initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy.

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