Associate Director, Clinical Data Management
14 Days Old
Associate Director, Clinical Data Management Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurixs dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicines next chapter with a new script to outmatch disease.
Position
Nurix is seeking a highly motivated, accomplished Associate Director of Clinical Data Management to join our growing biometrics organization.
Summary
The Associate Director of Clinical Data Management (CDM) will oversee the delivery and integrity of clinical data across multiple studies/programs. This role includes supporting process development, improving clinical data management infrastructure, ensuring adherence to industry guidelines, and assisting in developing departmental policies and operational guidelines. The candidate should have a successful track record in managing vendors and leading clinical data management activities, with excellent communication skills to work closely with medical study directors and clinical operations to maintain high data quality and integrity.
Additional responsibilities include, but are not limited to:
Job Responsibilities:
Lead clinical data management activities from study start-up to closeout
Manage and oversee vendors, including CROs, ensuring complete, accurate, and timely data delivery
Maintain inspection readiness through proper documentation, SOP adherence, and compliance
Coordinate with internal and external teams for planning and executing data management activities
Develop strategies for rapid study start-up and database lock to enhance productivity
Design eCRFs aligned with clinical protocols
Ensure comprehensive documentation such as eCRF specifications, validation plans, and data transfer agreements
Review data continuously, including individual subject data, datasets, and tables for reports and submissions
Collaborate on CDISC standards, FDA, ICH guidelines, and GCDMP standards
Contribute to the development of CDM SOPs and processes
Provide technical guidance to the data management team and vendors
Review and guide budget planning for clinical data management activities
Qualifications
Bachelors degree in a scientific discipline; Masters preferred
At least 10 years of clinical data management experience in the pharmaceutical industry for Associate Director level
At least 12 years of experience for Director level
Experience with Medidata Rave design and implementation
Knowledge of regulatory requirements and submission processes
Experience managing external vendors and evaluating capabilities
Proven ability to lead studies, build relationships, and manage stakeholders effectively
Adaptability to organizational changes
Strong organizational skills and communication abilities
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- Location:
- San Francisco, CA, United States
- Category:
- Management Occupations