Clinical Trial Systems & Process Manager

About the role

The Clinical Trial Systems & Process Manager is accountable for the strategic ownership, optimization, and governance of clinical trial systems and operational processes that enable high-quality, compliant, and inspection-ready execution of clinical development programs. This role ensures systems are scalable, inspection-ready, and aligned to CG Oncology’s late-stage development, BLA timelines, and future commercialization objectives. Ownership of CTMS and eTMF platforms is required, with Veeva Vault experience strongly preferred.

Location: Remote

Essential Functions

• 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

Qualifications

• 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.

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.

Total Rewards

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

• HIGHLY COMPETITIVE SALARIES   
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

Well-Being Benefits

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce.  These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire.  While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.

• 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

CG Oncology is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.