Clinical Trial Systems & Process Manager

CG Oncology

25d•Remote

About The Position

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

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.

Nice To Haves

Experience supporting late-stage trials and inspection readiness preferred.

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