Clinical Data manager
$120k - $160kKatalyst CRO
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
- Responsibilities: Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. Oversee Data Management... ...project documentation in an audit-ready manner. Support Lead Clinical Programmers in developing and managing Data Transfer...Suggested
- ...Responsibilities: Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation...Suggested
- Responsibilities: Lead the data quality evaluation by investigating all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports. Manage high complex studies and support specific activities of studies managed by other...SuggestedFor contractors
- ...Responsibilities: Excellent employment opportunity for a Sr. Clinical Data Manager in the San Francisco, CA area. Participate in the development, review and implementation of departmental SOPs, templates and processes Support budget and resource planning...Suggested
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