Clinical Operations

• Manage and execute complex clinical and pre-clinical projects from study initiation through closeout under the guidance of the Director, Clinical Affairs.
• Serve as the liaison between clinical and R&D, marketing, operational departments, investigators, study coordinators, advisors, and key opinion leaders.
• Manage CRO and other outside clinical vendors and/or consultants.
• Management of study budgets and timelines.
• Provide day-to-day direction and manage workload of project resources (CRAs, Data Managers, etc.).
• Development of investigator brochures and study subject enrollment enhancement materials.
• Development of investigational plans and clinical protocols.
• Qualification and screening of investigational sites.
• Negotiate investigational site contracts.
• Oversee investigational site training and investigator meetings.
• Oversee clinical study monitoring.
• Manage final study reports.
• Work with Regulatory Affairs to manage US and international regulatory submissions for the conduct of clinical studies and the approval of new products.
• Manage the preparation of pre-IDE and IDE submissions and clinical study-related interactions with the FDA.
• Development of standard operating procedures in compliance with US and Intl GCPs.
• Execute on clinical program strategy as directed by Director, Clinical Affairs.
• Manage KOL relationships.
• Drive clinical study communication to cross functional teams.

Senior Clinical Project Manager – Hybrid

Director, Clinical Operations

Clinical Research Operations Analyst

Associate Director, Clinical Operations

Clinical Program Manager, RN