Clinical Program Manager

Job Description

Job Description

Company Overview

At Vicarious Surgical, our mission is to give doctors the tools to provide the highest quality of care to patients around the globe. Our technology combines immersive virtual reality and proprietary human-like robotics, exponentially improving a surgeon's visibility and accuracy. We are a passionate and innovative team looking for motivated self-starters who want to make an impact.

Team Focus

As a part of the Clinical Affairs team, the Clinical Program Manager will lead all clinical study management activities to support ethical and evidence-based claims in alignment with business goals and objectives. This is a hands-on role, and the responsibilities include, but are not limited to, written and verbal guidance to develop / support pre-clinical work, pre-market and post-market clinical trial / registry design (company sponsored and physician sponsored), assessing and selecting trial infrastructure and execution systems (in house or through outsourcing), performing clinical evaluations, CRO selection / management, investigator selection, data analysis plans, and publication strategies. In this role, you will interact with R&D, Engineering, Marketing, Regulatory, and Quality team members to develop and compile information to support regulatory required activities and submissions. You are also responsible for ensuring that assigned studies are being conducted in accordance with Good Clinical Practices and all relevant regulations, policies, and procedures.

Responsibilities

• Provide leadership on clinical programs including setting goals, schedules, and project budgets in support of business objectives
• Develop clinical strategies working in collaboration with functional partners
• Develop and manage study budgets and timelines
• Author or review clinical study reports (CSRs)
• Manage the day-to-day clinical activities including developing, tracking, and managing budgets
• Lead the design, development and writing of pre-clinical and clinical study documents, including but not limited to, protocols, informed consent forms, case report forms (CRFs), investigator brochures, and other study-related documents.
• Implement the study protocol in line with local Institutional Review Board (IRB) or Ethics Committee (EC) requirements, local regulatory guidelines and Company policy ensuring that all studies are conducted in a compliant and ethical manner
• Perform all study-related activities as necessary including study and site identification, qualification, and initiation, management, communication, monitoring, and material distribution
• Monitor study progress, identify potential issues, and implement corrective actions
• Manage communication with clinical trial sites, vendors, and internal stakeholders
• Conduct regular site monitoring visits (as needed) to ensure data quality and compliance
• Resolve issues and give direction to Clinical Research Associates and sites
• Provides oversight of clinical trials to ensure that safety concerns and / or adverse events are identified and appropriate responses to such concerns are developed and executed
• Manage the entire clinical study process through close-out and publication
• Maintain accurate and up-to-date study documentation
• Define the standards required within the study process including but not limited to training, CRF completion, data capture, serious adverse events notification
• Develop and track study metrics on site performance, milestones, and deliverables, and devise and implement corrective actions
• Prepare periodic study status reports and maintain open communication (internal and sites)
• Collaborate on the develop of publication and presentation strategies with Marketing for overall clinical programs
• Manage all the end-to-end study costs within the approved time and budget parameters ensuring a cost-effective, ethical and results focused, publishable study to support the business as well as pricing and reimbursement considerations
• Perform literature searches, analyze data, and develop documents for evidence generation, study strategy / design, claim substantiation, and clinical evaluations
• Support Verification & Validation activities with development of plans, protocols, and reports.
• Responsible for the assurance of protocol compliance and data integrity by assuring adherence to GCPs, FDA regulations, EU MDR regulations, and department Standard Operational Procedures
• Participate in regulatory inspections and audits

Qualifications