Manager, Clinical Education (THV) bei Edwards

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

How you’ll make an impact:

Provides expertise and clinical insights on the device, procedure and protocol throughout the life cycle of the clinical investigation. Develops clinical education materials in connection with clinical investigations.

PRE-PROCEDURAL, INTRA-PROCEDURAL, POST-PROCEDURAL CASE SUPPORT

• Represent the Clinical Affairs Research Team during 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.
• Provide education on all aspects of the device, device handling, implantation and troubleshooting techniques related to equipment, tools and products required for device implants.
• Document procedural case observations for insights in investigating post procedural events. Support enrolment discussions and assistance with issue escalation with Principal Investigator and research team

EDUCATION 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 experience.
• Identify ongoing educational and project needs. Create and oversee the implementation of the identified projects and ongoing educational needs in partnership with key stakeholders. Act as a core team lead and provide consultation on various internal and/or field-related projects.
• Establish solid working relationships with appropriate levels of clinical/management in hospitals through the offering of excellent education support.

RESEARCH SUPPORT

• Develop material content and communications with investigational content for presentation at congresses and conventions and distribution to clinical sites, as required.
• Interface with investigation and clinical research staff to manage logistics associated with investigational meeting attendance, and protocol and device training, as required.
• Ensure device accountability by tracking the location of all clinical trial devices. Assist with managing device inventory to include par levels, expiration dates, and initiate shipments and returns of investigational products according to regulatory and company guidelines.
• Assist in providing site and Edwards personnel training including preparation/maintenance of study documents, completion of forms, understanding of examinations/assessments required.
• May assist/support commercial Clinical Field Specialists as required.
• Identifies and supports process improvement opportunities and implementation.
• Other incidental duties assigned by leadership

What you'll need (Required):

• Bachelor's Degree in related field required or/and Nurse degree or equivalent, 8 Years experience previous related medical device and/or clinical experience required
• Excellent written and verbal communication skills, presentation and interpersonal relationship skills.
• Excellent problem-solving and critical thinking skills.
• Strict attention to detail.
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
• Good understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting

What else we look for (Preferred):

• Clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT) or Cardiovascular Technician (RCIS) or related medical device, clinical, or Certification with ASAR as a Registered Cardiac Sonographer or equivalent experience preferred
• Full knowledge and understanding of cardiovascular science.
• Full understanding of cardiovascular anatomy, pathology and physiology
• Ability to manage confidential information with discretion.
• Ability to manage competing priorities in a fast paced environment.
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
• Adhere to all company 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.