Responsibilities Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc. Support GCP inspection readiness Demonstrate clear alignment with company Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence Performs other duties as assigned May involve travel Requirements: BS/BA in scientific discipline, MS or equivalent preferred, with at least 5 years related experience in a CRO/pharmaceutical/biologics/biotechnology company ----------Study/Vendor oversight experience Expert knowledge of Data Management processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH Experience working with EDC data management systems Understanding of ICH GCP as well as general knowledge of industry practices and standards Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11 Highly motivated and flexible, with excellent organizational and time management skills Ability to work independently and as part of a multi-disciplinary team Katalyst HealthCares & Life Sciences
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