Edwards Lifesciences Associate Clinical Development Specialist - Transcatheter Heart Valve in Irvine, California
Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.
Ensure successful product lifecycle management for NPD project, including:
•Develop and implement pre-clinical test strategy and provide guidance to NPD team members on strategy execution
•Design, prepare and conduct first-in-man product evaluations, including case support for proper product use
•Create Clinical Investigator Brochure
•Provide scientific rationale for product attributes and pre-clinical test results to regional clinical teams necessary to obtain site and country approvals
•Provide product expertise for new product introduction training for clinical and site personnel
• Ensure medical and scientific factors are considered during cross-functional product development project team meetings inclusive of literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports
Develop, review, and update clinical design control documents including technical summaries, clinical risk assessments, design of validation protocols and reports, Risk Management documents, Usability studies and reports. Generate technical and clinical documentation in moderately complex product development as deemed necessary by product team.
Provide case support and assistance to physicians during transcatheter implantation procedures.
Evaluate collected data documentation and imaging media, draw findings, and make recommendations to complete product evaluations, product complaint review and other required interim or final reports.
Identify ongoing educational and product needs related to clinical use of THV products. Oversee communication and implementation of the identified product and/or ongoing educational needs through partnership with key stakeholders. Act as a core team member and provide consultation on various internal and/or field-related clinical needs with product development cross-functional teams.
Create and present customized technical and clinical content to educate and train physicians, hospital personnel and employees on clinical matters relating to EW products. When necessary, lead training and provide hands-on coaching and mentorship in the field for new EW products.
Other incidental duties
Education and Experience:
Bachelor's Degree or equivalent in biological or life sciences, 1 year years experience previous related experience in Class II and III medical device technologies and/or clinical studies background Required
Bachelor's Degree or equivalent in engineering degree Preferred
• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery; Experience with documentation management systems (e.g., Ignite) preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Demonstrated problem-solving and critical thinking skills
• Good knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
• Good understanding of pre-clinical testing protocols, hospital environments and sterile techniques
• Good knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata)
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Ability to work in a team environment, including immediate supervisor and other team members in the section or group
• Ability to build stable working relationships internally
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.