Senior Clinical Trial Manager

Ovid Therapeutics•New York, NY
•$150,000 - $175,000•Hybrid

About The Position

Ovid Therapeutics is seeking an experienced Senior Clinical Trial Manager to lead day-to-day operational execution of clinical trials across its clinical development portfolio. The role manages studies from start-up through completion, ensuring delivery on time and within budget and compliance with Good Clinical Practice (GCP), applicable regulations, and company standard operating procedures (SOPs). The Senior Clinical Trial Manager serves as operational lead for assigned studies, coordinates cross-functional teams, and oversees CROs and other external vendors within an outsourced clinical development model. Prior experience as a study lead and experience with global clinical trials are required; pediatric and CNS clinical development experience are highly desirable. The position leads Phase II–III trials from study start-up through database lock and closeout, coordinating operational contributions to Clinical Study Report finalization. Responsibilities include study planning and oversight, start-up and enrollment activities, recruitment and retention strategies, risk management, status reporting, global team coordination, vendor and budget oversight, regulatory compliance, TMF inspection readiness, and collaboration with internal functions and external stakeholders. The role supports clinical operations across Ovid's broader development portfolio as priorities evolve. Ovid operates in a hybrid-work model. Candidates must be willing and able to work in the NYC office in coordination with their manager's expectations, department needs, and business needs. The base salary range is $150,000–$175,000; the actual offer depends on factors including experience, qualifications, skills, level offered, and performance expectations.

Requirements

  • At least 6 years of clinical research experience in the biotechnology or pharmaceutical industry, including management of complex clinical trials.
  • Demonstrated experience independently leading day-to-day operational execution of complex, high-volume clinical studies, with accountability for delivery, cross-functional coordination, and issue resolution.
  • Previous experience working in a small biotech or similarly lean, entrepreneurial organization.
  • Experience independently overseeing CROs and other external vendors in an outsourced clinical trial model and holding partners accountable for deliverables.
  • Experience leading global clinical trial operations, 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.
  • Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment.
  • Excellent written and verbal communication skills, stakeholder management, and problem-solving capabilities.
  • Must be willing and able to work in the NYC office in coordination with manager expectations and department and business needs.

Nice To Haves

  • CNS clinical development experience is highly desirable.
  • Pediatric clinical trial experience is a strong plus.

Responsibilities

  • Lead day-to-day operational execution of Phase II–III clinical trials from study start-up through database lock and study closeout, including operational contributions to Clinical Study Report finalization.
  • Develop and maintain study plans, timelines, budgets, milestones, and tracking tools.
  • Manage trial activities to support efficient, on-budget execution 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 with CROs and internal stakeholders.
  • Monitor study progress, identify risks or delays, and implement mitigation strategies and corrective actions.
  • Provide timely study status updates covering milestones, enrollment, risks, and budget forecasts.
  • Lead global study teams and facilitate study meetings to support communication, accountability, and timely decisions.
  • Manage CROs and external vendors, setting expectations and overseeing quality, performance, deliverables, and timelines.
  • Participate in vendor selection, bid defense meetings, contract and scope discussions, budget development, and financial oversight.
  • Coordinate interdependent vendor deliverables, timelines, and issue resolution.
  • Ensure compliance with regulations, ICH-GCP (including E6(R3)), company SOPs, and quality management processes; incorporate risk-based oversight.
  • Oversee Trial Master File completeness, quality, contemporaneous documentation, and inspection readiness.
  • Support internal and external audits and regulatory inspections.
  • Oversee study-level quality and compliance activities and implement corrective and preventive actions when appropriate.
  • Serve as the central operational point of contact for assigned studies and foster collaboration among internal teams, CROs, investigators, and 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 to leadership and stakeholders.
  • Support clinical operations and study execution across Ovid's broader development portfolio as priorities evolve.
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