Senior Clinical Trial Manager

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).

Prior experience as a study lead is essential.

Pediatric and CNS clinical development experience is highly desirable.

About Ovid Therapeutics

• Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to pioneering better, gentler medicines for the brain.
• The Company discovers and develops differentiated, small molecule medicines for neurological and neuropsychiatric disorders with significant unmet need.
• It is with curiosity, courage, and tenacity that, together, we work for meaningful change in the lives of patients and their families.
• With this sense of purpose and urgency we challenge the conventional and embrace the wisdom and thought that comes from diverse backgrounds and perspectives.
• Importantly, we understand the commitment we make to our patients, our broad community and to each other is based on the humanity that we share.

Responsibilities

• 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.
• This individual must manage trial-execution details, anticipate risks, resolve operational challenges, and keep studies on track in a lean, entrepreneurial biotech environment.
• 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.
• 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.
• Takes ownership of study execution, drives milestones, anticipates challenges, and follows through on commitments.
• Builds productive relationships with CROs, vendors, investigators, and internal stakeholders; sets clear expectations and manages performance effectively.
• Maintains high standards of compliance and documentation while identifying opportunities to improve study processes and operational efficiency.
• This is an opportunity for an experienced clinical study leader to make a direct impact on trial execution at a lean, neuroscience-focused biotechnology company.

Requirements

• Experience with global clinical trials is required.
• 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.
• Pediatric clinical trial experienceis 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.
• Identifies emerging risks, challenges assumptions constructively, and develops practical mitigation and contingency plans.
• Communicates clearly and proactively, builds trust, and fosters alignment across multidisciplinary and geographically dispersed teams.
• Thrives in a lean biotech environment, navigates ambiguity and changing priorities, and takes initiative to solve problems.

Preferred

• Experience in CNS clinical development is highly desirable.

Pay

• The base salary range for this position is $150,000 - $175,000.
• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, skills, level offered, and performance expectations.

The successful candidate will bring the operational discipline, flexibility, and vendor-management expertise needed to advance global clinical programs while working closely with cross-functional colleagues and external partners. Ovid operates in a hybrid-work model. Candidates applying must be willing and able to be in the NYC office in coordination with their manager's expectations, as well as department and business needs.