Clinical Trial Manager

The Position

Evommune is seeking a highly motivated Clinical Trial Manager to support the operational execution of company-sponsored clinical trials from study start-up through closeout.

The Clinical Trial Manager will support the Clinical Operations study lead in study execution and partner closely with CROs, vendors, clinical sites, and cross-functional teams to proactively manage timelines, risks, quality, and performance.

The successful candidate will bring independent clinical site monitoring experience gained in a CRA role, sponsor-side study management experience, and the ability to independently drive assigned study activities in a fast-paced, resource-conscious biotechnology environment.

Key Responsibilities

Study Execution

• Support the end-to-end operational execution of assigned clinical trials, including study start-up, site activation, enrollment, maintenance, database lock, and closeout activities.
• Develop and maintain detailed study timelines, trackers, dashboards, and operational plans.
• Proactively identify risks to key study milestones, including site activation, enrollment, data quality, and database lock.
• Drive operational issues through resolution and escalate significant risks with clear recommendations and proposed mitigation strategies.
• Demonstrate ownership, responsiveness, urgency, and consistent follow-through across assigned study activities.
• Deliver high-quality work against time-sensitive deadlines and take accountability for commitments and study deliverables.

CRO & Vendor Oversight

• Oversee CRO and third-party vendor performance to ensure delivery within scope, budget, quality expectations, and established timelines.
• Establish clear expectations and hold CROs and vendors accountable for agreed-upon deliverables and performance standards.
• Review and analyze monitoring reports, key performance indicators, study metrics, quality trends, and risk logs.
• Identify and address performance gaps proactively, escalating concerns and implementing corrective or mitigation plans as appropriate.
• Partner with the Clinical Operations study lead and CROs on site selection strategy, activation planning, monitoring activities, and enrollment forecasting.
• Build effective working relationships with CRO and vendor partners while maintaining appropriate oversight and accountability.

Cross-Functional Collaboration

• Collaborate closely with Clinical Development, Data Management, Regulatory, Safety, Clinical Supply, Biometrics, and other cross-functional partners to resolve operational issues and achieve key study milestones.
• Provide clear, concise, and actionable study-status updates through dashboards, reports, presentations, and study-team meetings.
• Communicate emerging risks, dependencies, decisions, and required actions to internal stakeholders in a timely manner.
• Contribute to the development and review of clinical protocols, protocol amendments, informed consent forms, study plans, manuals, and other trial-related documentation.
• Build collaborative relationships and communicate clearly, professionally, and constructively across functions and organizational levels.

Site & Study Oversight

• Support and independently conduct site qualification, initiation, routine monitoring, oversight, and closeout activities, as needed.
• Conduct co-monitoring or oversight visits with CRO monitors when appropriate to evaluate site performance, protocol compliance, data quality, and monitoring effectiveness.
• Maintain strong and productive working relationships with investigators and clinical site personnel.
• Review site performance, protocol deviations, monitoring findings, data listings, query trends, and other study information to identify potential operational or quality concerns.
• Ensure Trial Master File completeness, quality, timeliness, and compliance in collaboration with CRO partners and internal stakeholders.
• Support audit and regulatory inspection readiness throughout the lifecycle of the study.
• Oversee Investigational Product release coordination and site activation readiness.
• Monitor clinical data listings and summary tables to identify trends, discrepancies, or data-quality concerns.
• Oversee biologic sample collection, shipment, reconciliation, and assay-result tracking.
• Support study closeout, document reconciliation, database-lock readiness, and final vendor deliverables.

WHAT SUCCESS LOOKS LIKE

• Assigned studies and study activities are executed on time, within budget, and to appropriate quality standards.
• Risks and performance concerns are identified early, clearly communicated, and mitigated effectively.
• CROs and vendors are actively managed and held accountable to high performance standards.
• Monitoring reports, study metrics, data trends, and site performance are reviewed thoughtfully and translated into appropriate actions.
• Cross-functional partners receive clear, timely, and actionable study updates.
• Key clinical trial milestones are achieved through effective collaboration and operational follow-through.
• Clinical sites are effectively supported and operational issues are resolved promptly.
• Trial documentation remains complete, accurate, current, and audit- and inspection-ready.
• The Clinical Trial Manager demonstrates ownership, urgency, sound judgment, and a consistent commitment to high-quality execution.

Qualifications

• Bachelor’s degree in a scientific, health-related, or relevant field required; advanced degree a plus.
• 5+ years of progressive clinical operations experience.
• Independent clinical site monitoring experience gained in a CRA role is required, including experience conducting site qualification, initiation, routine monitoring, and closeout visits.
• Both direct clinical site monitoring experience and sponsor-side clinical operations experience are required.
• At least 2 years of sponsor-side study management experience is required.
• Experience supporting Phase 1 or Phase 2 clinical trials.
• Hands-on CRO oversight experience is required, including monitoring performance, reviewing deliverables, metrics, and monitoring reports, resolving performance issues, and escalating operational risks.
• Experience supporting global clinical trials is strongly preferred, ideally with ownership of a regional, functional, vendor, or operational component.
• Demonstrated experience working cross-functionally with partners such as Clinical Development, Data Management, Regulatory, Safety, Clinical Supply, and Biometrics to achieve meaningful clinical trial milestones.
• Demonstrated ability to proactively identify risks, drive issue resolution, and deliver high-quality work against time-sensitive deadlines.
• Strong working knowledge of ICH-GCP requirements and applicable clinical trial regulations.
• Experience reviewing clinical data listings, protocol deviations, monitoring reports, risk logs, and study-performance metrics.
• Experience supporting Trial Master File quality, completeness, reconciliation, and inspection readiness.
• Ability to manage multiple priorities and operate effectively in a fast-paced, small-company environment.
• Strong organizational, analytical, critical-thinking, and problem-solving skills.
• Excellent written and verbal communication skills.
• Demonstrated ability to build effective relationships with clinical sites, CROs, vendors, and internal stakeholders while maintaining accountability for performance.
• Proficiency in Microsoft Office applications.
• PMP certification is a plus.
• Up to 20% travel may be required.

Compensation

The salary range for this position is $120,000 - $150,000 and the position may be eligible for performance-based bonuses and/or equity-linked compensation.  Salary ranges are determined by role, level, and location, as well as additional factors such as job-related skills, experience, and relevant education or training. We offer Company-sponsored benefits, including comprehensive health, dental, and vision plans, as well as pet insurance. In addition, we provide a 401(k) plan, ample time-off programs, paid parental leave, life insurance, disability insurance, and an employee referral bonus program.

Evommune is proud to be an equal opportunity employer and will consider all qualified applicants for employment.