Clinical Data manager

Katalyst CRO; San Francisco (CA); On-site; USD 120,000 - 160,000; Part time

Job summary

A leading clinical research organization is seeking a Clinical Data Manager to lead data management for clinical trials. You will ensure compliance with guidelines and optimize data processes. The ideal candidate has a relevant degree and 5–7 years of experience in the pharmaceutical industry. This contract role offers an annual salary range of $120,000–$160,000.

Qualifications

• 5–7 years of data management experience in pharmaceutical or biotechnology industries.
• Strong expertise in project/program management and stakeholder management.
• Knowledge of CDISC, SDTM, and CDASH standards.

Responsibilities

• Lead all aspects of clinical trial data management.
• Conduct EDC build and user acceptance testing.
• Ensure compliance with regulatory guidelines.

Skills

Project management

Stakeholder management

Data cleaning

Database management

Regulatory guidelines knowledge

Education

BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics

Tools

Web-based EDC systems

MedDRA

WHO Drug

Job description

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