Basic Function and Scope of the Position: Provides clinical support and strategies for diagnostic product development to achieve clearances and approvals in the US and internationally. Provides study management and assures successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures. Reviews, assesses and interprets data from ongoing and completed studies. Oversees and manages clinical project personnel and/or consultants. Conducts clinical compliance activities. Manages clinical study budgets. Provides supervision and/or guidance to other clinical development personnel. May be responsible for multiple clinical studies. Tasks and Responsibilities: •Responsible for the day to day management of clinical trial projects including development of project timelines (utilizing Microsoft Project software), study budgets and project management plans. Reports project status to senior management. •Responsible for the management of assigned clinical trials including investigator selection, analysis and establishment of enrollment strategies, and preparation of trial related documentation (protocols, case report forms, consent documents, letters of agreement, confidentiality agreements). •Submits protocols and other documents to Institutional Review Boards / Ethics Committees with follow through to ensure successful outcome. •Leads clinical sub-teams and reports sub-team activities to core team. •Responsible for identifying and selecting investigators. Builds relationships with external clinical sites. •Works with business development to contract external sites, consultants, vendors, contract research organizations (CROs), etc. •Manages activities performed by consultants, CROs and vendors including initial identification of a suitable partner, definition of responsibilities, preparation of communication plan, defining division of responsibility, monitoring of milestones and budget, review of monthly status reports, and interactive management of CRO to ensure project success. •Monitors study and ensures adequate monitoring of study is conducted by clinical sub-team. •Manages clinical budget within stated financial goals. •Reviews, assesses and interprets data from ongoing and completed studies, and prepares reports as required. •Writes abstracts, papers, and manuscripts related to study results as required. •Monitors compliance with all company standard operating procedures (SOPs), GCP, FDA and applicable international regulations concerning clinical activities. •Reviews all unanticipated adverse device effects (UADEs), ensures medical review and reporting requirements are met, and that all company procedures are complied with. •Maintains project files including: ethics committee approvals; curricula vitae of investigators and study personnel; package insert, instructions for use, and user guides; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment. •Participates in the conduct of internal and external audits and inspections of clinical studies. •Compiles reviews and concludes device complaints; ensures corrective action is taken as needed. •Manages multiple clinical studies in parallel, through direct reports and/or other support staff, as appropriate. •Writes and/or reviews clinical sections of regulatory submissions and product labeling and ensures compliance with applicable regulations. •Compiles, reviews and concludes device complaints. Ensures corrective action is taken, as needed. •Performs personnel related supervisory duties as applicable, including selection, development, and performance evaluation of personnel to ensure the efficient operation of the team. •Writes and/or reviews clinical study protocols and ensures compliance with applicable regulations. •Evaluates clinical data/information and prepares reports. •Participates on product development core teams as the clinical representative for assigned projects. •Participates in the development of clinical strategies and development plans for products in development. •May manage a team of clinical development professionals. Mentors junior staff including those that are not direct reports. •Creates and implements departmental procedures (including project management processes and SOPs) in compliance with industry standards and regulatory requirements. •May provide input and support for post-clinical activities and market launch of product. •May participate in organizational initiatives. All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.