Clinical Data manager
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-01-12
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-01-12
Job specializations:
-
IT/Tech
Data Analyst, Database Administrator, Data Security, Data Warehousing
Job Description & How to Apply Below
Join to apply for the Clinical Data Manager role at Katalyst CRO.
South San Francisco, CA • $120,000–$160,000
• 2 weeks ago.
- 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.
- 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, 21
CFR 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.
- Entry level
- Contract
- Information Technology
- Pharmaceutical Manufacturing
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