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.
Key ResponsibilitiesClinical Trial Management - 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.
CRO and Vendor Oversight - 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.
Site Management and Monitoring Oversight - 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.
Study Start-Up and Regulatory Support - 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.
Budget and Financial Oversight - 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.
Compliance and Quality - 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.
Cross-Functional Collaboration & Communication - 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.
Travel Requirements - Up to 20%, including travel to investigator meetings, study sites, vendor meetings, or other clinical activities as needed.
Qualifications - Bachelor's degree in life sciences, nursing, public health, or related field required.
- Advanced degree (MS, MPH, PharmD, or PhD, or equivalent) preferred.
Experience - 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.
- 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.
What we offer: - Industry competitive compensation
- Annual target bonus
- Stock options
- 401K plan
- Career advancement opportunities
- Monthly town halls to share business and scientific updates
Work Hard, Stay Well - 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
Lifestyle- Casual work environment
- 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)
Have Fun! We believe in work/life balance and Fun is at the core of our Core Values. In addition to department and company happy hours, we have regular company-wide and department lunches and social events (ie Padres games, summer picnic, holiday party, bring your kids to work day).
Neomorph is headquartered in San Diego, California.
