Clinical Data Manager
2 months ago
Katalyst HealthCares & Life Sciences is seeking a highly skilled Clinical Data Manager to lead our clinical data management activities. As a program-level lead data manager, you will be responsible for overseeing data collection, coding, and cleaning by vendors, as well as collaborating with internal and external partners to ensure the success of our clinical studies.
Key Responsibilities- Lead database build activities, including cross-functional review of eCRF content and user acceptance testing.
- Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and internal data reviews.
- Collaborate with internal and external partners, including Biostatistics, Statistical Programming, and Clinical Operations.
- Establish cross-functional, internal data review plans and coordinate data cuts/transfers.
- Review CRO data management plans and CRF completion guidelines.
- BS/BA in scientific discipline.
- At least years of clinical data management experience in a pharmaceutical/biologics/biotechnology company.
- Expert knowledge of clinical processes and efficient design/build of an EDC data management system.
- Experience leading initiatives/projects for SOP, process, and standards development within clinical data management.
- Expert knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH.
Katalyst HealthCares & Life Sciences offers a dynamic and collaborative work environment, with opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for clinical data management, we encourage you to apply for this exciting opportunity.
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