Clinical Operations Lead

 

Vicarious Surgical is seeking a Clinical Operations Lead Role to join our team in Bangalore, India. This role will be tasked with supporting clinical activities associated with our surgical robot.

Vicarious Surgical is a US based next generation robotics company developing a disruptive technology with the goal of increasing the efficiency of surgical procedure, improving patient outcomes, and reducing healthcare costs.

This is a terrific opportunity to join our company at a very exciting time and be a key member of a team of mission-driven and kind individuals with diverse experiences to lead Vicarious into its next phase of market disruption. 

This individual will be employed by a Professional Employer Organization (PEO), but doing work specifically for Vicarious Surgical.

Working hours of Monday through Friday (Office hours start at 3PM to ensure significant overlap with US hours)

This high visibility position will involve all activities related to Clinical Operations. By working with the existing team, the Clinical Operations Lead will ensure timely completion of clinical activities while ensuring a vibrant, motivating team-oriented working environment. The Clinical Operations Lead will oversee many operational aspects of clinical trials (operational and detailed logistics), including management of external vendors, and will coordinate and track internal and external resources, timelines, and budgets.

Responsibilities

• Responsible for all operations of Company sponsored clinical trials, clinical budgets, and timelines for clinical activities
• Oversight of departmental training and monitoring of departmental compliance with SOPs, GCP/ICH guidelines and QC/QA procedures
• Direct the management and maintain strong, effective professional relationships with vendors, consultants, investigators, and other external clinical trial participants
• Assistance with the identification of “top physicians” in a given therapeutic area as required to identify new clinical trial sites or new clinical advisors
• Assistance with the generation, analysis and presentation of clinical data including manuscripts, abstracts and oral presentations
• Attends and participates in various in-house and external meetings
• Establishment, tracking, and reporting of appropriate performance metrics to presenting clinical trial progress and performance
• Initiate new tools, procedures and processes to improve efficiency, review systems for efficiencies and compliance with regulations; revises SOPs as needed
• Some travel to pertinent conferences and sites as needed
• Other duties as assigned

Qualification Requirements

• Bachelor’s degree or equivalent required, preferably in a medical or scientific field
• Not less than 10 years of clinical trial experience in a medical device, pharmaceutical, biotech, or CRO industrial setting including 2+ years of clinical operations management experience
• Demonstrated ability to work in a team-oriented environment
• Management skills
• Excellent interpersonal verbal/written communication skills
• Attention to detail with excellent analytical and problem-solving skills is required
• Strong background in planning, timelines, budgeting, and clinical trial management. Demonstrated successful management
• of simultaneous trials across multiple sites
• Excellent working knowledge of FDA & EMA regulatory process, FDA, GCP, ICH regulations and guidelines
• Strong computer skills (Excel, Work, PowerPoint, Microsoft Project) and solid presentation skills are essential
• Ability to travel