Clinical Trial Systems Manager
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Job Description
Clinical Trial Systems & Process Manager at CG Oncology ensuring high-quality execution of clinical development programs. Own and manage clinical trial systems and processes, ensuring compliance and readiness.
Responsibilities:
- 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.
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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