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Sponsor Oversight Lead (R5439)
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
At Genmab, we’re committed to building extra[not]ordinary futures, together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven, to our business that is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions and have a lot of fun and bring a ton of care in pursuing them.
If this inspires you and feels like a fit, then we’d love to have you join us.
The Role & Department
As Sponsor Oversight Lead, you will be in the Clinical Operations Team and 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. You will report to the Senior Director, Team Lead, Trial Management, and work closely with Clinical Operations, other teams and departments, and vendors.
Key responsibilities include:
- 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 - what you must have
- At least 2 years of experience with monitoring and/or co-monitoring of clinical trials (Phase I experience preferred)
- Preferably 3 years of experience as Trial Manager or Lead CRA from a CRO and/or pharmaceutical company
- Extensive knowledge of working with clinical 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 can work independently as well as within global teams
- You are result- and goal-oriented and committed to contributing to the overall success of Genmab
About You - additional qualities you bring to the table
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted in science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
Where you will work
This role can be located in Copenhagen, Denmark; Utrecht, the Netherlands; or Princeton, NJ USA and is hybrid or remote.
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the results of our strong company culture, a deep passion for innovation, and a desire to transform cancer treatment and serious diseases.
When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; are a critical part of changing the lives of patients around the world through transformative cancer treatment.
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
Our commitment to diversity, equity, and inclusion
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. Learn more about our commitments on our website.
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.
Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation. This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.
Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer. For more than 20 years, Genmab’s vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that make an impact on people’s lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab’s proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.