Biomedical Data Stewardship Mgr

Client: Biotech Location: Remote Duration 1 year + extensions We are seeking an experienced Veeva Database Manager with strong expertise in clinical data standards to join our Biomedical Data Stewardship team. This role is responsible for contributing to the design of clinical trial databases within Veeva Clinical Data Management System (CDMS), ensuring compliance with internal data collection standards and supporting high-quality data entry for clinical trials. The ideal candidate will have hands-on experience programming clinical trial databases, applying CDISC/CDASH standards, and collaborating with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs. Day To Day Responsibilities • Consult on the design of electronic data capture (EDC) databases using Veeva CDMS. • Review current RAVE DES data collection specifications and suggest Veeva CDMS structures. • Ensure alignment to CDISC, CDASH, SDTM, and related industry standards for clinical data collection and reporting, where necessary. • Maintain and update standard libraries, forms, edit checks, and controlled terminology in line with evolving regulatory guidance. • Work closely with Biostatistics, Clinical Programming, Safety, and Data Management to ensure smooth data flow and integration across systems. • Develop and maintain documentation including standard database specifications, edit check programming guides, and controlled terminology. Qualifications • Bachelor’s degree in Life Sciences, Computer Science, or related field; advanced degree preferred. • 4+ years of experience in Clinical Data Management, with at least 2+ years managing Veeva CDMS databases. • Strong knowledge and hands-on experience with CDISC CDASH implementation; exposure to SDTM a plus. • Proven track record of building and maintaining clinical trial databases in compliance with regulatory and industry standards. • Strong understanding of clinical trial processes, ICH-GCP, and regulatory requirements. • Excellent problem-solving, communication, and cross-functional collaboration skills. Preferred Skills • Experience with other EDC platforms (e.g., Medidata Rave, Oracle InForm) in addition to Veeva. • Familiarity with data visualization and analytics tools (e.g., Spotfire, SAS, R). • Experience working in global teams within a pharmaceutical, biotechnology, or CRO environment. • Knowledge of data exchange standards (e.g., CDISC ODM, Define.xml).