Clinical Trial Manager, Clinical Operations (on-site

The Clinical Trial Manager (CTM) is responsible for the operational leadership and execution of assigned clinical trials from study start-up through close-out. The CTM ensures studies are conducted in accordance with the protocol, applicable regulatory requirements, ICH-GCP guidelines, and company/CRO SOPs, while maintaining high standards for quality, timelines, and budget.

Reporting to the VP of Clinical Operations, the CTM partners with cross-functional teams and external vendors to advance the company’s clinical programs. This role is expected to provide hands‑on oversight of early-phase oncology studies, including complex site activation, enrollment, safety, and data‑delivery activities. This is a hybrid position based at our site in San Diego.

• Lead the day-to-day operational management of assigned clinical trials from study start-up through close-out, with particular focus on early-phase oncology development.
• Develop and maintain integrated study timelines, operational plans, trackers, and key performance indicators to ensure milestones are achieved.
• Coordinate cross-functional study activities across clinical development, clinical operations, data management, biostatistics, regulatory, pharmacovigilance/safety, quality, CMC, translational, and other relevant functions.
• Identify operational risks, elevate issues appropriately, and implement mitigation and contingency plans to protect study timelines, quality, and patient safety.
• Support operational planning for dose‑escalation and dose‑expansion cohorts, including readiness for safety review and dose‑escalation decision meetings, as applicable.

• Manage and oversee CROs, clinical vendors, and consultants, with clear accountability for scope, timelines, deliverables, quality, and budget.
• Monitor vendor performance using agreed metrics and governance processes; drive timely resolution of performance or quality issues.
• Participate in vendor identification and selection, RFP processes, bid defenses, scope‑of‑work development, and contract review.

• Oversee site feasibility, selection, activation, initiation, monitoring, and close‑out activities conducted by CROs or monitors.
• Review monitoring reports, enrollment metrics, site performance data, protocol compliance, and quality trends; ensure follow‑up actions are completed.
• Develop and support site engagement and enrollment strategies appropriate for competitive oncology indications and patient populations.
• Partner with cross‑functional teams and vendors to address site‑level operational barriers, including recruitment, retention, sample logistics, and study drug supply.

• Drive or support study start‑up activities, including site feasibility, essential document collection, investigator meeting planning, and activation readiness.
• Collaborate with Regulatory and CRO partners on submission‑related activities, responses, and documentation for applicable health authorities and ethics committees/IRBs.

• Manage assigned study budgets, forecasts, accrual inputs, and clinical trial expenditures in partnership with Finance and Clinical Operations leadership.
• Review CRO and vendor invoices for accuracy, milestone achievement, and alignment with contractual terms; identify and resolve discrepancies.

• Ensure clinical trials are conducted in compliance with ICH‑GCP, applicable global regulatory requirements, protocol requirements, and company SOPs.
• Support inspection and audit readiness, including timely identification, documentation, escalation, and remediation of quality issues.

• Partner closely with internal stakeholders to ensure operational plans remain aligned with clinical development objectives and program priorities.
• Provide clear, concise study status updates, risk assessments, and decision points to the VP of Clinical Operations and other senior leaders.
• Contribute to the development and continuous improvement of clinical operations processes, tools, and infrastructure as the…