Field Clinical Engineer
Join a highly innovative medical device company as a Field Clinical Engineer in the area of cardiac electrophysiology. You will work with key clinicians in the US and abroad to investigate novel robotic diagnostic and therapeutic technologies for the treatment of cardiac arrhythmias. Includes all aspects of pre-clinical and clinical study execution to support our regulatory submissions for product approval. As part of an experienced clinical team, you will contribute to product development, clinical study implementation and training of clinical research personnel in procedures and tools for company research globally. This individual is responsible for conducting animal and pre-clinical studies, working with the engineering teams to evaluate and test products, develop pre-clinical test protocols, interface with investigators and participate in early clinical evaluations. He/she contributes to study design and implementation, including protocol development, case report form development, data monitoring, data analyses, report writing, and interfacing with investigational sites, CRO organizations, clinical study steering committees and Data Safety and Monitoring Boards (DSMB). Has responsibility for staying current with applicable regulations. Ensures that the clinical studies are conducted per established policies, procedures, regulations, and Good Clinical Practices (GCP). Responsible for working with clinical sites and contract research associates to maintain high data compliance in clinical trials. Works closely with Key Opinion Leaders (KOLs), recruits and trains clinical investigators and coordinators. Has demonstrated a high degree of competence in clinical support of electrophysiology procedures, especially in the field of cardiac ablation. Has credibility with clinical investigators and has experience in all aspects of clinical science programs. Provides collaborative feedback and support of research and development objectives to design and validate new products and product enhancements.
Essential Duties and Responsibilities:
• Responsible for executing pre-clinical and clinical trials for the company. This includes animal studies, research and feasibility studies, multi-center
clinical trials toward regulatory submissions and other scientific trials at investigator sites.
• Assists with development of pre-clinical and clinical trial protocols and case report forms and study training plans and materials
• Performs clinical trial monitoring, obtains and analyzes clinical data, and generates reports for regulatory filings.
• Interfaces with investigational sites, CRO organizations, clinical study steering committees and physician advisors.
• Helps define User Needs documents and product specifications.
• Establishes and builds relationships with internal stakeholders and external customers, suppliers or vendors to support strategic business initiatives.
• Interfaces and manages KOLs worldwide and supports the assessment, recruitment and training of investigators and appropriate clinical sites.
• Interfaces with clinical investigators and Institutional Review Boards to ensure timely completion of clinical trials and submission of marketing applications.
• Conducts clinical and technical site audits and internal audits, as necessary to support regulated activities.
• Assures accurate records are maintained and provides periodic reports.
• Works collaboratively with QA/RA, R&D and other departments to ensure appropriate clinical and regulatory activities to support Project Teams.
• Maintains and works to Company SOP's. Ensures that procedures are sufficient and adequate for conducting regulated clinical trials. Develops and implements procedures and work instructions, as necessary, to ensure conformance with Good Clinical Practices.
• Reviews promotional and educational materials for appropriate clinical content.
• Supports Product Complaint investigations, as required.
• Supports all clinical matters related to the product development and manufacturing teams and contributes to the design and execution of all design validation studies.
• Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines; assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy, and legibility.
• Functions independently in the field and interacts with all levels of medical and scientific professionals.
• Prepares and delivers technical and clinical research for publication and training.
• Stays current in regulations and emerging new regulations affecting clinical trials and research to ensure clinical systems, processes, procedures and training appropriately reflect current global standards.
• Supports Regulatory and Quality in preparing responses to regulatory agency questions regarding clinical studies.
• Collaborates with Quality Assurance and other departments to ensure Clinical Trials department compliance.
• Performs other duties as assigned/desired commensurate with individual achievement goals and career growth objectives.
Individual must be motivated to work independently as well as with teams. They must be able to manage multiple tasks and prioritize appropriately. Must be detail oriented with good written, verbal and organizational skills. PC proficient (e.g., Windows, Word, Excel, PowerPoint).
• Bachelor's Degree in Engineering, Science, Management, or applicable field.
• This position requires a minimum 5 years' experience managing medical and interventional technology in a clinical studies setting, preferably in the field of cardiac ablation, and experience explaining and supporting the use of sophisticated technology to clinical investigators. Previous experience writing abstracts, protocols and white papers highly desirable.
• Team-oriented individual with a commitment to personal and professional growth by both teaching and learning from other team members.
• Superior strategic and tactical problem-solving and decision-making skills, analytical and organizational skills.
• Must have excellent communication skills, both written and oral
• Must have outstanding public speaking and presentation skills
• Proven ability to interface, interact with and manage KOLs and other Electrophysiologists in Europe and the US.
• Broadly respected as knowledgeable, thorough, responsive, trustworthy and reliable by KOLs.
• Demonstrated ability to manage, motivate and partner with clinical staff and related activities.
• Must be able to work independently, have excellent organizational skills to define and prioritize projects and execute them on time and within budget.
• Ability to achieve goals in a teamwork environment through interaction with individuals not under their direct control.
• Familiarity with desktop computer office software
• Ability to travel (up to 50% US and/or international), and participation in professional activities outside of normal business hours are required.