Senior Manager Risk Based Monitoring, Trial Strategy and Delivery job in Princeton
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New Jersey (NJ),
Princeton
| Job Code: | R10056 |
| Employer: | Genmab |
| Category: | Clinical Research |
| Location | |
| Country: | United States |
| State: | New Jersey (NJ) |
| City: | Princeton |
| Post Date: | 03/27/2024 |
| Description | |
|
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, which 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. The Role & Department The Senior Manager Risk Based Monitoring, Trial Strategy and Delivery will be responsible for supporting the CTTs in timely planning and execution of Risk Based Quality Management deliverables in accordance with standard operating procedures (SOPs), policies and practices from study start-up, during conduct to closure. The Senior Manager Risk Based Monitoring will join the RBQM team, Trial Strategy and Delivery and support the CTTs with development of Risk Assessment and Mitigation Plan (RAMP), identification of critical to quality factors, Parameters with Quality Tolerance Limits (PQTLs), Key Risk Indicators (KRIs), thresholds for action and monitoring tactics, as well as identification of de-risking initiatives and mitigation activities. The Senior Manager Risk Based Monitoring will closely collaborate with relevant RBM vendor to ensure proper implementation of applicable RBQM model selected for the study according to agreed roles and responsibilities between Genmab and RBM vendor. Responsibilities As a Senior Manager Risk Based Monitoring you will drive and/or independently perform:
Requirements For this role we need you, who have previous experience in working with RBQM adoption, including identification of critical data and process, associated risks and monitoring strategies. You will have a key role in bringing together all the relevant skill areas involved in monitoring activities. You are motivated to work in a company culture with an entrepreneurial spirit along with highly competent colleagues. Genmab experiences rapid growth and we are in the starting phase of building the future Risk Based Quality Management. Hence, it is imperative that you thrive in a changing environment where you have great opportunities to influence the path and outcome. You recognize yourself in following descriptions:
For US based candidates, the proposed salary band for this position is as follows: $35,625.00---$59,375.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses. About You
Locations 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. About Genmab Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. 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 is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website https://www.genmab.com/privacy . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL 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. | |
ref: (R10056) 31 days ago
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