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.
Senior Clinical Trial Manager
Are you looking for an opportunity where you can take the lead in delivering key trial management elements on oncology trials and ensure sponsor engagement? We a looking for a Senior Clinical Trial Manager driven by ensuring a one-team culture with CROs and who excels in contributing to great teamwork and working environment. Join our innovative, hardworking, and ambitious team collaborating in a high performing and high pace environment to improve the lives of cancer patients.
Working in Clinical Operations is exciting, intense, challenging, and fun at the same time. The dedication, collaborative and knock-your-socks-off spirit of our employees are what really shapes our team. From day one, the onboarding program makes sure that you accomplish trainings, get settled with our IT systems and that you team up with your mentor, colleagues, and relevant stakeholders.
ResponsibilitiesThe Sr Clinical Trial Manager is accountable for delivery of selected and/or regional activities within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g. DM, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development).
The principal responsibilities are:
·Develop operational plans, manuals and charters for the trial·Review protocol and protocol amendments and other trial documents as necessary·Create and coordinate the writing of Investigational Medicinal Product (IMP) Plan·Coordinate the development of the Trial Oversight Plan·Review the Clinical Trial Application (CTA) submission package·Review site regulatory documents·Develop Global Master ICF·Coordinate resolution of site or monitoring issues working with CRO or other applicable vendorsSite Selection and Management:
Vendor Management and Oversight:
Trial Execution and Monitoring:
Key Competencies
Moreover, you meet the following personal requirements:
For US based candidates, the proposed salary band for this position is as follows:
$114,375.00---$190,625.00The 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
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.
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