Senior Manager, Clinical Programming
Not Disclosed•Full-TimeHybrid
location_on30, Holohan Drive, Plainsboro Township, Middlesex County, New Jersey, 08536, United States
At Genmab, we are dedicated to building "extra not ordinary" futures by developing groundbreaking antibody medicines that change lives and the future of cancer treatment. For 25 years, our innovative and collaborative team has invented next-generation antibody technology platforms, resulting in a proprietary pipeline including bispecific T-cell engagers and antibody-drug conjugates. By 2030, our vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
We strive to create a global workplace where individuals' unique contributions are valued and drive innovative solutions. Our people are compassionate, candid, and purposeful, rooted in science yet determined to have fun while pursuing big ambitions. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose.
The Senior Manager, Clinical Programming serves as a pivotal leader in establishing, governing, and ensuring the integrity of Study Data Tabulation Model (SDTM) standards. This role exists to support the portfolio's ultimate objective of data quality and consistency across programs and systems. You will perform sponsor oversight of relevant programming activities on the Biometrics vendor and act as a subject matter expert on industry standards, regulations, and processes.
In this position, you will bridge the gap between Clinical Programming and External Data Management, ensuring data standardization alignment and proactively resolving issues that impact SDTM deliverables. You will work closely with Digital Solutions and IT to support the implementation of future strategies and technology-enabled processes for clinical trials. Your work will directly influence the quality of submission data packages and drive a culture of continuous process improvement and high-level customer service.
Genmab maximizes the efficiency of an agile working environment to support employee work-life balance. Our offices are crafted as open, community-based spaces designed to connect employees while being immersed in our powerful laboratories. Whether you are in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
We are looking for individuals who are genuinely passionate about our purpose, bring precision and excellence to their work, and believe in our rooted-in-science approach to problem-solving. You should be a generous collaborator capable of working in teams with a broad spectrum of backgrounds, taking pride in enabling the best work of others. We value those who can grapple with the unknown, be innovative, and work hard while not being afraid to have a little fun.
Genmab is committed to protecting your personal data and privacy. Please refer to our Job Applicant Privacy Notice for details on how we handle your data in connection with your application. If you are applying for a position in the Netherlands, please note that Genmab's policy for all permanently budgeted hires is initially to offer a fixed-term employment contract for a year, with the possibility of renewal for an indefinite term based on performance and business conditions.
Genmab is an equal opportunity employer. We consider qualified applicants regardless of background, race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other protected characteristic.
Work model: Hybrid
30, Holohan Drive, Plainsboro Township, Middlesex County, New Jersey, 08536, United States
Plainsboro Township, New Jersey
Master's degree in Statistics, Computer Science, or Life Sciences. Practical knowledge and experience using R to support clinical trials. Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation.
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Skills: Sas Programming, R, Cdisc, Fda, Ich, GCP, Clinical Research, Metadata Management, Clinical Data Management, Trial Management.
Education: Bachelor's degree in Statistics, Computer Science, or Life Sciences required; Master's degree in Statistics, Computer Science, or Life Sciences preferred.
Genmab is a biotechnology research firm headquartered in Valby, Denmark, specializing in the development of innovative antibody medicines. The company focuses on advancing treatments for cancer and other serious diseases by leveraging its expertise in creating novel antibody formats. These modalities include bispecific antibodies, antibody-drug conjugates, and immune-modulating antibodies designed to address unmet medical needs. The organization maintains a robust late-stage clinical pipeline featuring wholly owned programs aimed at delivering transformative therapies to patients globally.
With a strong international presence spanning North America, Europe, and the Asia Pacific region, Genmab operates as a rapidly growing entity in the biotechnology sector. The company culture emphasizes collaboration, integrity, and a shared passion for turning scientific discovery into accessible medicine. This environment encourages employees to innovate and build solutions while fostering a supportive community. For further details regarding its programs and operations, Genmab directs inquiries to its official website.
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Experience
6-8 yrs (Senior)
Education
Bachelor's degree in Statistics, Computer Science, or Life Sciences required
Job Type
Full-Time