Oversee data management activities to maintain consistency across trials including Case Report Form (CRF) design, Data Management Plans, CRF annotation, edit check programs, data entry and query status tracking, and database closure. Oversee database design, migration or expansion, including UAT and documentation. Proactively identify risks and execute risk mitigation strategies; Maintain timely communication with both upper management and cross-functional teams. Oversee the tracking of important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team as required. Perform reviews of clinical trial data to ensure all captured data follows the rules outlined by the protocol and Data Management Plan. Support cross-functional activities related to biometrics, regulatory submissions and clinical program development as needed Requirements:
BS degree in a life science or related field preferred. Minimum of 5+ years of CDM experience in biotech or pharmaceutical industry; or equivalent education and experience required. Ability to manage multiple programs, and multiple studies within a program. Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Experience supporting Phase 3 studies, BLA submission and FDA/MHRA audits. Proficient in CDMS (ex: Medidata, Clintrak), Microsoft Office Suite (ex: Word, Excel, PowerPoint). Understand the principles of clinical research (ex: ICH GCP, CDISC and GCDMP).
Katalyst CRO
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San Diego, CA