To support the in-vitro diagnostic field, the full-time Clinical Data Manager will oversee data management activities for companion diagnostics studies, ensuring timely and compliant data delivery while collaborating with cross-functional teams and external partners in a remote work environment. Key responsibilities Lead end-to-end clinical data management activities, including database design, data review, and quality control for companion diagnostic studies Manage EDC/CRF system design and validation, ensuring compliance with regulatory requirements and supporting database lock activities Collaborate with Biostatistics and Programming to develop submission-ready datasets for regulatory submissions and maintain data integrity throughout study execution Required qualifications Bachelor's degree in Data Science, Computer Science, Information Technology, or related field; advanced degree preferred 5-8 years of clinical data management experience in biotechnology, pharmaceuticals, or diagnostics Hands-on experience with CDISC standards and EDC platforms such as Medidata Rave or Oracle InForm Direct experience supporting oncology clinical trials or companion diagnostics strongly preferred Ability to interpret regulatory standards and manage multiple projects in a fast-paced environment
Get in touch with a Weatherby consultant today to learn more about this and other opportunities available now. ~7am - 5pm Monday through Friday ~100% general anesthesia for interventional radiology procedures ~ No trauma or OB procedures ~2 weeks per month, ongoing...
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