Senior Enterprise Systems Administrator

Posted 69ds ago

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Job Description

Senior Enterprise Systems Administrator leading CG Oncology’s enterprise clinical systems for global Phase I–III trials. Ensuring compliance and inspection readiness within a fast-paced biotech environment.

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

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:

  • HIGHLY COMPETITIVE SALARIES
  • ANNUAL PERFORMANCE/MERIT REVIEWS
  • ANNUAL PERFORMANCE BONUSES
  • EQUITY
  • SPECIAL RECOGNITION
  • FULLY REMOTE WORK ENVIRONMENT
  • REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
  • HOLIDAYS –In 2026 we will observe 14 holidays
  • RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
  • HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
  • HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
  • ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
  • LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
  • ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More