Contractor - Senior Clinical Data Manager (Hybrid or Remote) job in Princeton
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New Jersey (NJ),
Princeton
| Job Code: | R10362 |
| Employer: | Genmab |
| Category: | Clinical Research |
| Location | |
| Country: | United States |
| State: | New Jersey (NJ) |
| City: | Princeton |
| Post Date: | 03/23/2024 |
| Description | |
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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 As the Contractor, Senior Clinical Data Manager, you will be operationally responsible for tasks within the planning, start-up, conduct and closure of clinical trials from final synopsis and/or a Clinical Trial Team (CTT) is assigned. The Contractor, Senior Clinical Data Manager will represent Clinical Operations Data Management on the CTT, and with partners and/or Data Management/Statistical vendors. You may support the overall strategy and development of Clinical Operations by participating in task force initiatives within the department. Key responsibilities You will be part of the cross-functional trial specific CTT and be responsible for core deliverables such as clinical database design/setup, data collection, data validation, manual review, and timelines. All activities will be performed according to quality standards defined by regulations/standards, Genmab SOPs and ICH-GCP. • Act as the point of contact for DM activities for multiple trials, provide oversight of data collection and management per regulatory and industry standards • Provide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial teams • Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy. • Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy • Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure • Define and perform data quality checks and take action to ensure data quality • Provide oversight of key DM documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on DM expertise • Drive DM oversight of data releases/DBLs and ensure timely delivery of data deliverables in accordance with Genmab SOPs and ICH/GCP; ensure data quality for analysis and reporting; prepare for regulatory filings and inspections • Drive and support vendor qualification for data management; define/specify scope of work for functional tasks • Support process improvement and knowledge management by participating in or leading task forces/ projects Requirements - what you just have • Bachelor's degree in science or related area • 5-8+ years of experience in clinical data management experience in biotech/ pharma industry; significant hands-on end-to-end experience in clinical data management practices • Experience within oncology trials highly preferred • Experience with clinical trials and the drug development process • Significant experience leading data management activities for multiple clinical trials; proficient use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation; strong understanding of DM strategy • Experience and understanding of GCPs, SOPs, regulatory requirements and good data management practices • Experience with CDISC (SDTM) as well as data collection requirements in oncology trials preferred • Project management experience Furthermore, the following skills are part of your personal toolbox: • Planning and organizational skills • Team leadership skills • Problem solving and decision-making skills • Excellent written, verbal, and organizational skills • Quality mindset • Document creation and management skills • Process development skills • Being proactive and accountable • Analytical skills with the ability to interpret and present clinical data Where you will work This role can be located in Utrecht, The Netherlands or Princeton, New Jersey, U.S., and is hybrid. Remote is available for candidates not in commuting distance to Genmab. 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 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 result of our strong company culture, a deep passion for innovation, and 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; and are a critical part of changing the lives of patients around the world through transformative cancer treatment. 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 . | |
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