Own and lead CG Oncology’s clinical, quality, and regulatory enterprise systems (eTMF, CTMS, EDC, IRT, QMS, Veeva QualityDocs & Training, RIM Vault)
Ensure systems are inspection-ready, compliant, and adopted across global Phase I–III trials
Act as the business owner for systems strategy, validation oversight, continuous improvement, and user enablement
Partner with CROs and vendors to ensure data quality, timelines, and budget discipline
Play a visible role in regulatory inspections, audits, and submissions
Help shape how systems scale as CG Oncology grows its pipeline

Requirements

Have 7+ years of progressive experience supporting enterprise clinical and quality systems in biotech, pharma, or a CRO
Have supported full-cycle drug development (Phase I–III or I–IV), including audits or inspections
Understand GCP, ICH, FDA expectations, and clinical data stewardship deeply
Are comfortable owning systems, influencing cross-functional stakeholders, and working with external partners
Thrive in a small, fast-moving biotech environment where priorities evolve and ownership matters

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

eTMFCTMSEDCIRTQMSVeeva QualityDocsRIM Vaultdata qualityvalidation oversightcontinuous improvement

Soft Skills

leadershipinfluencingcross-functional collaborationuser enablementadaptabilityownershipcommunicationproblem-solvingstakeholder managementteamwork