As a part of the Clinical Affairs team, the Clinical 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 
• Manage the day-to-day clinical activities including developing, tracking, and managing budgets
• Lead multi-disciplinary team of clinical affairs personnel in the design, development and writing of pre-clinical and clinical study 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 initiation, management, communication, and monitoring
• 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 to publication
• 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 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

Qualifications

• Someone who is energetic, dynamic, hands-on, and self-motivated
• Bachelor’s degree or equivalent in science related/health field, or combination of equivalent education and experience in a medical or scientific setting
• Minimum of 5 years of professional experience with at least 3 years experience in Clinical Research as a Clinical Study Manager or Clinical Project Manager
• Must have a working knowledge of GCPs, medical device regulations (21CFR, MDD/MDR), and other global regulations, standards, and guidance
• Experience interacting with regulatory agencies (FDA, EU Notified Bodies, etc.) 
• Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
• Knowledge of medical terminology and human anatomy/physiology
• Ability to foster a collaborative team environment, multi-task, and work effectively in a fast-paced matrix environment
• Strong written, oral, and interpersonal skills to be able to effectively interface interdepartmentally, compose reports, and complete assignments
• Proficient computer skills in Microsoft Office and Google Platforms
• Willingness to travel up to 30% (Depending on COVID Restrictions)
• ACRP or SoCRA certification (Preferred)
• Medical device industry experience in robotics or imaging (Ideal)