CG Oncology logo
CG Oncology

Attacking Bladder Cancer for a Better Tomorrow

Clinical Trial Systems Manager

OperationsOperationsFull TimeRemoteSeniorTeam 11-50Since 2010H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

2 days ago

Salary

$123K - $145K / year

Seniority

Senior

Bachelor Degree6 yrs expEnglishGoogle Cloud PlatformVault

Job Description

• Own and manage clinical trial systems including CTMS, eTMF, and related platforms, Veeva Vault strongly preferred. • Define and maintain the clinical systems roadmap aligned to Phase 3 programs and rolling BLA milestones. • Lead system implementation, configuration, validation, upgrades, and lifecycle governance. • Design and standardize end-to-end clinical trial operational workflows. • Develop SOPs, templates, and training materials to support adoption and compliance. • Ensure compliance with GCP, ICH guidelines, 21 CFR Part 11, and computer system validation requirements. • Oversee data integrity, audit trails, user access controls, and validation documentation. • Partner cross-functionally with Clinical Operations, Data Management, Regulatory, Quality, IT, and CRO partners. • Maintain TMF completeness metrics and continuous inspection readiness dashboards. • Define KPIs and reporting dashboards to monitor operational health and risk. • Support internal audits and regulatory inspections. • Manage system vendors to ensure alignment with CG Oncology quality standards.

Job Requirements

  • Bachelor’s degree required, preferably in life sciences, Clinical Research, Biomedical Sciences, Health Sciences, Data Management, or related scientific discipline.
  • Advanced degree preferred.
  • Six (6) years of progressive experience in clinical operations, clinical systems ownership, or process management in a regulated biotech or pharmaceutical environment.
  • Hands-on experience with CTMS and eTMF systems required.
  • Experience supporting late-stage trials and inspection readiness preferred.

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 2025 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

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