Senior Enterprise Systems Administrator

CG Oncology

2d•Remote

About The Position

CG Oncology is advancing innovative oncology therapies through global Phase I–III clinical trials. As we scale, the quality, integrity, and usability of our clinical and quality systems are mission-critical. This role is not traditional “systems administration.” It is a hands-on systems ownership and leadership role with real authority over how clinical, quality, and regulatory systems enable execution, compliance, and growth. If you enjoy owning systems end-to-end, partnering with Clinical Ops, QA, Regulatory, and CROs, and building scalable, audit-ready infrastructure in a growing biotech, this is a meaningful next step.

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
Prefer roles where impact, accountability, and growth matter more than job titles alone

Nice To Haves

Oncology experience, small-biotech experience, and prior people leadership are strong pluses — but demonstrated performance and ownership matter most.

Responsibilities

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