Clinical Trial Manager, Clinical Operations (on-site)

Neomorph • San Diego, CA

3d • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in life sciences, nursing, public health, or related field required.
• 7+ years of progressive experience in clinical research or clinical operations within biotech, pharmaceutical, or CRO environments.
• Demonstrated experience managing Phase 1 and/or other early-phase clinical trials; study start-up and close-out experience strongly preferred; oncology trial experience strongly preferred.
• Hands-on experience leading clinical trial execution balancing strategic oversight with detailed operational follow-through.
• Proven experience managing CROs and external vendors including performance oversight, issue escalation, and budget accountability.
• Working knowledge of oncology trial operations, including complex eligibility criteria, safety-intensive studies, dose-escalation/expansion designs, and time-sensitive site and data workflows.
• Strong understanding of ICH-GCP, FDA requirements, and applicable global clinical trial regulations and processes.
• Experience partnering with CMC and supply-chain stakeholders to support clinical supply readiness and continuity, including experience with clinical trial supply projections.
• Experience partnering with clinical translation and pharmacology stakeholders to support clinical trial PK/PD sample collection, reconciliation, and trouble-shooting.
• Strong clinical trial financial management skills, including budget tracking, forecasting, accruals, invoice review, and change-order management.
• Excellent project management, organizational, problem-solving, and communication skills, with the ability to manage multiple priorities in a fast-paced environment.
• Ability to build effective relationships across functions and with external partners, influence without direct authority, and communicate clearly with senior leadership.

Nice To Haves

• Advanced degree (MS, MPH, PharmD, or PhD, or equivalent) preferred.
• Experience helping build, scale, or optimize clinical operations processes and infrastructure is preferred.
• Experience using AI to help create efficiencies and scale workload is a plus.

Responsibilities

• 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, escalate 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 company grows.

Benefits

• Industry competitive compensation
• Annual target bonus
• Stock options
• 401K plan
• Career advancement opportunities
• Monthly town halls to share business and scientific updates
• Comprehensive medical, dental, and vision plans for employees and their dependents
• Health and Dependent Care FSA and HSA Plan with monthly Neomorph contribution
• Employee Assistance Program
• 10 holidays + Winter Shutdown + 3 weeks of vacation time with additional accruals after 2nd year of employment, separate sick leave.
• Supplemental pay for Pregnancy Disability Leave
• Paid Parental Leave for employees with a newborn child or a child placed with them for adoption or foster care
• Volunteer days off each year to spend time contributing to causes you care about
• Flexible work schedule
• Access to onsite gym
• Onsite space to store your bicycle (or surfboard)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level