This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.The Senior Specialist, Clinical Education (Remote-West Coast) TMTT-PASCAL will develop clinical education materials in connection with clinical investigations.Key Responsibilities:PRE-PROCEDURAL, INTRA-PROCEDURAL, POST-PROCEDURAL CASE SUPPORT Represent the Clinical Affairs Research Team during complex clinical trial cases with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during clinical trial implants, including contingency planning to address unforeseen occurrences in support of assigned clinical investigations.Document procedural case observations for insights in investigating post procedural events. Support enrollment discussions and assistance with issue escalation with Principal Investigator and research teamEDUCATION SUPPORT Educate and train physicians, hospital personnel on technical matters related to investigational products and procedures through conducting and/or coordinating one-on-one ad hoc training sessions and in-service structured education programs.Throughout clinical investigations, provide physicians and medical staff with required follow-up support to ensure continuity of education and technical support related to all aspects of clinical research.Develop and continuously improve training materials, training tools, and curriculum, based on clinical trial experienceRESEARCH SUPPORT Ensure device accountability by tracking the location of all clinical trial devices. Manage inventory to include par levels, expiration dates, and initiate shipments and returns of investigational products according to regulatory and company guidelines.Collaborate with product development teams to provide feedback and recommend solutions on device iterations and new device development.Required Qualifications:Bachelor's Degree in in related field5 years’ experience of previous related medical device and/or clinical experienceAbility to travel up to 50%Preferred Qualifications:Clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Cardiac Sonographer (RDCS/RCS), Radiologic Technologist (RT), Operating Room Technician (ORT), Cardiovascular Technician (RCIS)Experience in interventional cardiology or cardiothoracic surgeryAdditional Skills: Proven expertise in MS Office Suite and ability to operate general office machineryStrong written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skillsExcellent problem-solving and critical thinking skillsFull knowledge and understanding of cardiovascular scienceFull understanding of cardiovascular anatomy, pathology and physiologyFull understanding of medical device regulatory requirements and documents, device accountability and adverse events reportingAbility to manage confidential information with discretionStrict attention to detailAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projectsAbility to interact with senior internal and external personnel on significant matters often requiring coordination between organizationsAdhere 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/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
Edwards Lifesciences
Sacramento California
United States
Education - Excluding Post Secondary
(No Timezone Provided)
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.The Senior Specialist, Clinical Education (Remote-West Coast) TMTT-PASCAL will develop clinical education materials in connection with clinical investigations.Key Responsibilities:PRE-PROCEDURAL, INTRA-PROCEDURAL, POST-PROCEDURAL CASE SUPPORT Represent the Clinical Affairs Research Team during complex clinical trial cases with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during clinical trial implants, including contingency planning to address unforeseen occurrences in support of assigned clinical investigations.Document procedural case observations for insights in investigating post procedural events. Support enrollment discussions and assistance with issue escalation with Principal Investigator and research teamEDUCATION SUPPORT Educate and train physicians, hospital personnel on technical matters related to investigational products and procedures through conducting and/or coordinating one-on-one ad hoc training sessions and in-service structured education programs.Throughout clinical investigations, provide physicians and medical staff with required follow-up support to ensure continuity of education and technical support related to all aspects of clinical research.Develop and continuously improve training materials, training tools, and curriculum, based on clinical trial experienceRESEARCH SUPPORT Ensure device accountability by tracking the location of all clinical trial devices. Manage inventory to include par levels, expiration dates, and initiate shipments and returns of investigational products according to regulatory and company guidelines.Collaborate with product development teams to provide feedback and recommend solutions on device iterations and new device development.Required Qualifications:Bachelor's Degree in in related field5 years’ experience of previous related medical device and/or clinical experienceAbility to travel up to 50%Preferred Qualifications:Clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Cardiac Sonographer (RDCS/RCS), Radiologic Technologist (RT), Operating Room Technician (ORT), Cardiovascular Technician (RCIS)Experience in interventional cardiology or cardiothoracic surgeryAdditional Skills: Proven expertise in MS Office Suite and ability to operate general office machineryStrong written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skillsExcellent problem-solving and critical thinking skillsFull knowledge and understanding of cardiovascular scienceFull understanding of cardiovascular anatomy, pathology and physiologyFull understanding of medical device regulatory requirements and documents, device accountability and adverse events reportingAbility to manage confidential information with discretionStrict attention to detailAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projectsAbility to interact with senior internal and external personnel on significant matters often requiring coordination between organizationsAdhere 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/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.