Senior Clinical Trial Associate
Ovid Therapeutics
Summary
Ovid Therapeutics is seeking a detail-oriented and organized Senior Clinical Trial Associate (CTA) to support the execution of clinical studies and the day-to-day activities of the Clinical Operations team. This role will be a key support role to the clinical operations study lead, managing components of clinical trials with minimal direction and oversight ensuring that they are executed to expected and specified quality standards.
Job description
Position Overview
Ovid Therapeutics is seeking a detail-oriented and organized Senior Clinical Trial Associate (CTA) to support the execution of clinical studies and the day-to-day activities of the Clinical Operations team. This role will be a key support role to the clinical operations study lead, managing components of clinical trials with minimal direction and oversight ensuring that they are executed to expected and specified quality standards.
This position offers an opportunity to build a strong foundation in clinical operations, with potential to expand responsibilities and develop toward broader clinical trial management activities over time.
Key Responsibilities
- Provide administrative and operational support for clinical trials throughout start-up, conduct, and closeout.
- Coordinate with internal study team members, clinical sites, CROs, and external vendors to track study activities, follow up on outstanding deliverables, and support timely execution of clinical trial activities.
- Support the maintenance and oversight of the electronic Trial Master File (eTMF), including document collection, filing, quality control, and tracking of outstanding documents to ensure completeness, accuracy, and inspection readiness.
- Maintain and update clinical trial tracking tools, including site activation status, study milestones, enrollment metrics, essential document tracking, and other operational deliverables.
- Coordinate clinical study team meetings, including scheduling, preparation of agendas, documentation of meeting minutes, and tracking of action items through completion.
- Assist with the preparation, distribution, and tracking of study-related materials, including study manuals, site communications, training documentation, and other essential study documents.
- Support quality assurance, audit readiness, and regulatory compliance activities as needed.
- Maintain effective communication with internal and external stakeholders to support study execution and enrollment objectives.
- Identify opportunities to improve administrative processes, documentation practices, and overall study coordination.
- As experience develops, take on additional clinical operations responsibilities and contribute to broader study management activities.
Qualifications
- Bachelor’s degree in life sciences, nursing, healthcare, or a related field preferred.
- Approximately 2–3 years of experience in clinical research, clinical trial coordination, or clinical operations for a CRO or sponsor.
- Familiarity with clinical trial documentation, regulatory requirements, and study site processes.
- Knowledge of ICH-GCP guidelines and applicable regulatory requirements preferred.
- Strong organizational skills and attention to detail, with the ability to manage multiple tasks and deadlines.
- Clear written and verbal communication skills and the ability to work effectively with cross-functional teams.
- A proactive, flexible approach and willingness to learn, accept feedback, and take on new responsibilities.
- Experience using clinical trial management systems (CTMS), electronic trial master file (eTMF) platforms, or other clinical research systems is desirable.
- Experience supporting neuroscience or CNS clinical trials is a plus.
Key Competencies
- Organization and attention to detail: Maintains accurate documentation and follows through on commitments.
- Communication and collaboration: Builds effective working relationships with clinical sites, vendors, and internal colleagues.
- Time management: Balances competing priorities and keeps deliverables on track.
- Adaptability and initiative: Responds constructively to changing priorities and proactively addresses routine issues.
- Learning agility: Demonstrates curiosity and a willingness to expand clinical research knowledge and responsibilities.
Professional Development
This role is designed for a clinical research professional who wants to deepen their understanding of clinical trial execution and build a career in clinical operations. As the individual gains experience and demonstrates strong performance, there may be opportunities to assume additional responsibilities in study coordination, site management support, and other clinical trial activities.
Requirements
- Bachelor’s degree in life sciences, nursing, healthcare, or a related field preferred
- Approximately 2–3 years of experience in clinical research, clinical trial coordination, or clinical operations for a CRO or sponsor
- Familiarity with clinical trial documentation, regulatory requirements, and study site processes
- Knowledge of ICH-GCP guidelines and applicable regulatory requirements preferred
- Strong organizational skills and attention to detail
- Clear written and verbal communication skills
- Proactive, flexible approach and willingness to learn
- Experience using CTMS, eTMF platforms, or other clinical research systems desirable
- Experience supporting neuroscience or CNS clinical trials is a plus
Company overview
Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing innovative therapies for rare neurological disorders. Founded in 2014 and publicly traded on NASDAQ under the symbol OVID, the company employs its BoldMedicine® approach to create transformative treatments for patients with severe neurological conditions. Ovid's primary focus is on reducing seizures and improving the lives of individuals affected by rare epilepsies and seizure-related neurological disorders. The company has built a differentiated pipeline of potential first-in-class medicines, with its most advanced investigational drug, OV101 (gaboxadol), currently in clinical development for Angelman syndrome and Fragile X syndrome. Additionally, Ovid is collaborating with Takeda Pharmaceutical Company to develop OV935 (soticlestat) for rare developmental and epileptic encephalopathies. With 23 employees and headquarters in New York City, Ovid Therapeutics represents a specialized player in the neurological therapeutics space, targeting underserved patient populations with significant unmet medical needs.