Senior Clinical Trial Manager

Position Summary

Ovid Therapeutics is seeking an experienced, highly motivated Senior Clinical Trial Manager to lead the day-to-day operational execution of clinical trials across its clinical development portfolio. This individual will be responsible for managing clinical studies from start-up through completion, ensuring trials are delivered on time, within budget, and in compliance with Good Clinical Practice (GCP), applicable regulations, and company standard operating procedures (SOPs). As the operational lead for assigned studies, the Senior Clinical Trial Manager will coordinate cross-functional teams and manage contract research organizations (CROs) and other external vendors within an outsourced clinical development model. Prior experience as a study lead is essential. This individual must manage trial-execution details, anticipate risks, resolve operational challenges, and keep studies on track in a lean, entrepreneurial biotech environment. Experience with global clinical trials is required. Pediatric and CNS clinical development experience is highly desirable.

Key Responsibilities

Clinical Study Leadership and Execution

• Lead the day-to-day operational execution of Phase II–III clinical trials from study start-up through database lock and study closeout, coordinating operational contributions to Clinical Study Report (CSR) finalization.
• Develop and maintain study plans, timelines, budgets, milestones, and tracking tools to ensure effective trial delivery.
• Manage day-to-day clinical trial activities to ensure studies are executed efficiently, within budget, and in compliance with applicable regulatory requirements.
• Lead study start-up activities, including feasibility assessments, country and site selection, site activation, and enrollment planning.
• Develop and implement patient recruitment and retention strategies in collaboration with CROs and internal stakeholders.
• Proactively monitor study progress, identify potential risks or delays, and implement mitigation strategies and corrective actions.
• Provide accurate and timely study status updates, including key milestones, enrollment performance, risks, and budget forecasts.
• Lead global study teams and organize and facilitate study-specific meetings, ensuring clear communication, accountability, and timely decision-making.

CRO and Vendor Management

• Manage CROs and multiple external vendors within an outsourced clinical development model, ensuring clear expectations, accountability, quality, and performance.
• Participate in vendor selection, bid defense meetings, contract and scope discussions, budget development, and ongoing financial oversight.
• Hold CROs and external vendors accountable for contractual deliverables, study milestones, quality expectations, and agreed-upon timelines.
• Proactively identify performance issues, implement corrective actions, and escalate concerns as appropriate.
• Coordinate interdependent vendor deliverables, timelines, and issue resolution to maintain alignment with study objectives and milestones.

Regulatory Compliance and Study Quality

• Ensure clinical trials are conducted in compliance with applicable regulatory requirements, ICH-GCP (including E6(R3)), company SOPs, and established quality management processes.
• Incorporate risk-based approaches into study oversight.
• Oversee the completeness, quality, and inspection readiness of the Trial Master File (TMF), ensuring essential documentation is maintained contemporaneously and in accordance with applicable regulations, GCP, and company SOPs.
• Support preparation for and management of internal and external audits and regulatory inspections.
• Oversee study-level quality and compliance activities, identifying potential issues and implementing corrective and preventive actions as appropriate.

Cross-Functional Collaboration

• Serve as the central operational point of contact for assigned studies, fostering collaboration across internal teams, CROs, investigators, and other external stakeholders.
• Work closely with Clinical Development, Clinical Operations, Data Management, Biostatistics, Medical Writing, Drug Safety, Regulatory Affairs, and Clinical Supplies.
• Communicate study status, risks, resource needs, and key decisions clearly and proactively to leadership and stakeholders.
• Support clinical operations and study execution across Ovid's broader development portfolio as priorities evolve.

Qualifications and Experience

• Minimum of 6 years of clinical research experience within the biotechnology or pharmaceutical industry, including experience managing complex clinical trials.
• Demonstrated experience independently leading the day-to-day operational execution of complex, high-volume clinical studies, with accountability for study delivery, cross-functional coordination, and issue resolution.
• Previous experience working within a small biotech or similarly lean, entrepreneurial organization.
• Demonstrated ability to independently oversee CROs and other external vendors in an outsourced clinical trial model, holding partners accountable for deliverables and proactively identifying and mitigating risks.
• Experience leading global clinical trial operations is required, including coordination across international sites, vendors, and functional teams.
• Experience managing study timelines, budgets, vendor deliverables, risks, and cross-functional dependencies.
• Strong working knowledge of GCP, clinical trial regulations, SOPs, and essential clinical study documentation.
• Experience in CNS clinical development is highly desirable.
• Pediatric clinical trial experience is a strong plus.
• Strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
• Excellent written and verbal communication skills, with demonstrated stakeholder management and problem-solving capabilities.

Key Competencies

• Study Leadership and Accountability: Takes ownership of study execution, drives milestones, anticipates challenges, and follows through on commitments.
• Vendor and Stakeholder Management: Builds productive relationships with CROs, vendors, investigators, and internal stakeholders; sets clear expectations and manages performance effectively.
• Risk Management and Judgment: Identifies emerging risks, challenges assumptions constructively, and develops practical mitigation and contingency plans.
• Communication and Collaboration: Communicates clearly and proactively, builds trust, and fosters alignment across multidisciplinary and geographically dispersed teams.
• Adaptability and Initiative: Thrives in a lean biotech environment, navigates ambiguity and changing priorities, and takes initiative to solve problems.
• Quality and Continuous Improvement: Maintains high standards of compliance and documentation while identifying opportunities to improve study processes and operational efficiency.