Remote Principal Clinical Specialist.

Job Summary

This position is responsible for providng clinical input to support company quality and regulatory activities, along with providing clinical, technical, and educational support to assist in meeting sales, customer support. Activities include assessment of risk level associated with the clinical use of Terumo Cardiovascular products. This position will research and analyze the risks, benefits, features and hazards related to product design, user instructions/training and potential defects and/or malfunctions. The position is responsible for supporting commercial, product development, quality, and regulatory departments to achieve the overall Company goals. This position requires work periodically on weekends, evenings, and nights. Requires travel up to 90% and international travel may be required.

Job Details/Responsibilities

1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

2. Sales Support: Complete necessary documentation and phone calls (customer service), immediately notify representatives regarding issues or problems requiring follow-up, serve as effective Terumo CV representative to physicians, physician assistants, RNs, perfusionists, auto-transfusionists, and support staff as applicable regarding Terumo CV products, services, and clinical support. Maintain current knowledge regarding products, procedures, Terumo CV programs, services, and competitive products, maintain open, effective communication with all customers and other Terumo CV associates. Assess and analyze product safety concerns, researching available medical data and references.

3. Clinical and Technical Support: Represent Terumo CV during surgeries of products to provide clinical support, troubleshooting, and other technical assistance. Provide follow-ups in hospitals and clinics, provide support with field clinical investigations in assigned institutions, receive technical inquiries by telephone, research solutions to questions or problems, provide on-call support as needed for surgeries, troubleshooting, follow-up, etc. including evenings and weekends.

4. Educational Support: Educate and train clinicians, hospital personnel and office staff on technical matters relating to our products through conducting and/or coordinating training and education programs. Assist internal departments with training new Clinical Specialists and Sales Representatives and provide additional training and resources for hospital staff to enable them to conduct training for their personnel (“train the trainer”) if required.

5. Seminars/Trade Show/Symposiums: Participate and present in technical seminars, symposia, and trade shows. Offer clinical and technical information and assistance to customers during these various events.

6. Clinical Trials & Product Development Support: Participate in clinical trials and studies to support marketing and regulatory activities for new and existing products. Provide input to Product Development for new product development through knowledge of customer/clinical requirements. Participate in formative, summative and design validations from a user standpoint.

7. Ensure documentation/training is in compliance with hospital operating room protocol tracking system.

8. Establish and maintain a network of outside medical professionals for consultation regarding clinical product safety and use. Provide medical and clinical consultation related to product design, instructions for use, training and actions taken to reduce/minimize patient risk.

9. Participate in the evaluation of product complaints to assist in the determination of the action required. Perform Health Hazard Evaluations associated with the potential product defects or malfunctions, determine potential for patient injury/death, and recommend actions to reduce and minimize patient risk.

10. Participate in periodic risk review processes for all Terumo Cardiovascular products.

11. Assist with laboratory and product investigations.

12. Quality Support: Complete necessary documentation and information collection, immediately notify representatives regarding issues or problems requiring follow-up, serve as effective support staff for all Terumo products.

13. Maintain effective communication with Terumo Associates.

14. Perform other duties as assigned.

Qualifications/ Background Experiences

Requires a four-year college degree in nursing, cardiovascular, or technical discipline and a minimum of ten years of experience in hospital/clinic, cardiovascular setting (operating room environment) or a high school diploma or equivalent and certification in appropriate medical discipline with twelve years of clinical experience in hospital/clinic, cardiovascular setting (operating room environment). Experience working in a company setting as a clinical specialist highly desired. Basic computer software skills, i.e., Microsoft Office.