Manager, Clinical Operations

OVID Therapeutics

Ovid Therapeutics (NASDAQ: OVID) is a New York-based biopharmaceutical company using its BoldMedicine™ approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The company's lead investigational medicine, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935/TAK-935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of rare developmental and epileptic encephalopathies (DEE).

POSITION

This Manager, Clinical Operations will manage multiple global clinical trials on day to day basis based on adherence ICH GCP.

RESPONSIBILITIES

• Managing all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met
• Coordinating the negotiation of budgets and providing oversight for payments per contracts
• Reviewing monitoring reports, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered; coordinating with CROs on site selection, IRB submissions, site initiation and close-out planning
• Tracking patient recruitment and progress to study timelines; supporting safety reporting; maintaining and reporting metrics for clinical study and CRO delivery performance
• Performing and/or overseeing site monitoring visits for clinical trials as needed Ensuring clinical supplies accountability records are maintained
• Providing oversight to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP quality standards and consistency with company SOPs
• Participating with CROs and providing support to sites to prepare for clinical audits and to respond to audit findings conducted by internal QA and external regulatory agencies
• Compile study progress reports to upper management

REQUIREMENTS:

• BA/BS degree in health or biologic science (BS/BA/ BScN or higher)
• 5+ years clinical study management experience in biopharmaceutical industry
• Global clinical trial experience
• Management of Phase III clinical trials
• Vendor Management experience (central labs/CRO/imaging etc)
• Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials is required
• Effective oral and written communication, and interpersonal skills are required

PREFERRED QUALIFICATIONS:

• Rare Disease or CNS experience highly preferred
• International clinical trial experience and knowledge of other country regulatory requirements is preferred.

*Equal Opportunity Employer/Veterans/Individuals w/Disabilities

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