Sponsor Oversight Lead
Job SummaryAbout Us
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
Reporting to the Director, Team Lead, Trial Management, the Sponsor Oversight Lead (SOL) will be responsible for the planning, conduct and coordination of trial oversight activities together with internal and external stakeholders to ensure quality and integrity of the data within and across Genmab clinical trialsKey Accountabilities
- 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
- Bachelor of Science degree required; Nursing degree is a plus.
- Minimum 3+ 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 are 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 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.
If you would like additional information about this position before applying using the link, please contact Jannie Jensen, recruiter (email@example.com)
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