Join to apply for the Clinical Data Manager role at Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the Clinical Data Manager role at Katalyst CRO Leads all clinical data management activities for assigned clinical studies assuring all timelines are met with best quality. Responsible for overseeing creation and approval of DM study documentation by vendors/CROs (i.e. CRFs, completion guidelines, database specs, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans). Reviews clinical data and metrics to identify data quality trends, compliance with the protocol, consistency of data across subjects and sites and potential risks to timelines. Reviews the deliverables of DM vendors to ensure accuracy and consistency with expected practices. Coordinates cross-functional data review meetings with the clinical team. Manage the collection of data issues, reporting of findings and communication of post-review status. Produces regular data listings for the clinical team and other functional areas. Responsibilities Leads all clinical data management activities for assigned clinical studies assuring all timelines are met with best quality. Responsible for overseeing creation and approval of DM study documentation by vendors/CROs (i.e. CRFs, completion guidelines, database specs, edit checks, data review plans, data transfer specifications, SAE reconciliation plans, and external vendor data reconciliation plans). Reviews clinical data and metrics to identify data quality trends, compliance with the protocol, consistency of data across subjects and sites and potential risks to timelines. Reviews the deliverables of DM vendors to ensure accuracy and consistency with expected practices. Coordinates cross-functional data review meetings with the clinical team. Manage the collection of data issues, reporting of findings and communication of post-review status. Produces regular data listings for the clinical team and other functional areas. Requirements: 5 years of experience as a Lead CDM at a small-midsized pharma/biotech company; BS degree. Experience leading all DM functions for clinical studies including global studies including but not limited to data management plans, edit specifications, utilizing data dictionaries, electronic data transfers, data quality reviews and reporting. Expertise with Medidata RAVE and other databases such as IVRS/IWRS, Central Imaging etc. Knowledge of SDTM & CDISC. Need to be comfortable wearing multiple hats and working hands on to support any in-house DM work as required. Seniority level Seniority level Associate Employment type Employment type Contract Job function Job function Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Clinical Data Manager” roles. San Francisco Bay Area $160,000.00-$180,000.00 2 weeks ago San Francisco Bay Area $116,000.00-$145,000.00 2 weeks ago Alameda, CA $86,700.00-$173,300.00 2 days ago Associate Clinical Data Management Director Alameda, CA $160,000.00-$226,500.00 1 week ago Senior Manager, Clinical Data Management Senior Manager, Clinical Data Management San Francisco Bay Area $138,000.00-$172,000.00 2 weeks ago Alameda, CA $86,700.00-$173,300.00 4 days ago Principal Data Manager - Clinical Data Quality Leader Senior Manager, Clinical Data Management Alameda County, CA $190,000.00-$225,000.00 3 weeks ago Associate Director, Clinical Programming Alameda, CA $179,500.00-$255,500.00 1 week ago Mountain View, CA $71,000.00-$100,000.00 1 day ago Associate Director, Clinical Data Management Menlo Park, CA $105,000.00-$131,000.00 3 weeks ago Senior Director, Clinical Data Management Redwood City, CA $265,000.00-$295,000.00 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Katalyst CRO
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