Join to apply for the Clinical Data Manager role at Katalyst CRO. South San Francisco, CA • $120,000–$160,000 • 2 weeks ago. Responsibilities Lead all aspects of clinical trial data management from study start‑up through database lock and study close. Conduct the EDC build and user acceptance testing (UAT), data cleaning and reconciliation, query issue resolution, and database locks. Optimize data collection, flow, and access across EDC and non‑EDC sources. Ensure accuracy, consistency, completeness, and CDISC compliance of all clinical databases. Act as a key member of the Clinical Operations team. Develop and maintain data management documentation, including CRFs, data management plans, edit check specifications, data review plans, and data transfer agreements. Design electronic CRFs for data capture. Perform data entry, cleaning activities, discrepancy management, and query resolution. Conduct data validation checks and implement quality control measures to ensure accuracy and completeness. Collaborate with study team members to resolve data‑related issues and discrepancies. Generate and review data listings, summaries, and reports for data review. Serve as a primary or backup resource for data management issues. Ensure compliance with GCP, CDISC standards, and other relevant regulations. Contribute to the development and validation of data management software. Requirements BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics, or equivalent industry experience. 5–7 years of data management experience in pharmaceutical or biotechnology industries. Strong expertise in project/program management and stakeholder management. Knowledge of industry standards (CDISC, SDTM, CDASH). In‑depth understanding of regulatory guidelines: ICH, GCDMP, 21CFR Part 11. Proven ability to preemptively identify data and system issues and mitigate risks to data quality. Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data. Experience in developing and implementing clinical data management standards and procedures. Experience with web‑based EDC systems and medical coding dictionaries such as MedDRA and WHO Drug. Seniority level Entry level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO
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