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About the Role
Ovid Therapeutics is seeking an experienced Senior Clinical Trial Manager to lead the day-to-day operational execution of clinical trials, ensuring timely, within-budget, and compliant delivery. This role involves managing cross-functional teams and vendors in an outsourced model within a lean, entrepreneurial biotech environment.
Responsibilities
- Lead the day-to-day operational execution of Phase II-III clinical trials from study start-up through database lock and study closeout.
- Develop and maintain study plans, timelines, budgets, milestones, and tracking tools.
- Manage day-to-day clinical trial activities to ensure efficient execution, budget adherence, and regulatory compliance.
- 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.
- Proactively monitor study progress, identify potential risks or delays, and implement mitigation strategies.
- Provide accurate and timely study status updates, including key milestones, enrollment performance, risks, and budget forecasts.
- Lead global study teams and facilitate study-specific meetings.
- Manage CROs and multiple external vendors, 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 timelines.
- Coordinate interdependent vendor deliverables, timelines, and issue resolution.
- Ensure clinical trials are conducted in compliance with applicable regulatory requirements, ICH-GCP, company SOPs, and quality management processes.
- Oversee the completeness, quality, and inspection readiness of the Trial Master File (TMF).
- 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.
- 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.
Requirements
- Minimum of 6 years of clinical research experience within the biotechnology or pharmaceutical industry.
- Experience managing complex clinical trials.
- Demonstrated experience independently leading the day-to-day operational execution of complex, high-volume clinical studies.
- 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.
- Experience leading global clinical trial operations is required.
- 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.
- 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.
- Willing and able to be in the NYC office in coordination with manager's expectations, department, and business needs.
Skills
- Study Leadership and Accountability
- Vendor and Stakeholder Management
- Risk Management and Judgment
- Communication and Collaboration
- Adaptability and Initiative
- Quality and Continuous Improvement
Location
- New York, NY
Work Type
- Hybrid
Experience Level
- Senior
Salary/Compensations
- $150,000 - $175,000
About the Company
- 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.