Edwards Lifesciences Senior Clinical Implant Specialist in North Ryde, Australia
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.
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 enrollment discussions and assistance with issue escalation with Principal Investigator and research team
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.
Provide field training and guidance to new Clinical Specialists.
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
May develop material content and communications with investigational content for presentation at congresses and conventions and distribution to clinical sites.
May interface with investigation and clinical research staff to manage logistics associated with investigational meeting attendance, and protocol and device training.
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. May support leadership of team initiatives
Collaborate with product development teams to provide feedback and recommend solutions on device iterations and new device development.
Assist in Clinical Monitoring activities
Other incidental duties
Education and Experience:
Bachelor's Degree in Life Sciences or related field, minimum of 5 years experience of experience in clinician education, patient education, product specialist or management role Required
Clinician experience in intraoperative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) Preferred
Other: Experience in interventional cardiology or cardiothoracic surgery preferred
Proven expertise in MS Office Suite and ability to operate general office machinery
Strong written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
Excellent problem-solving and critical thinking skills
Full knowledge and understanding of cardiovascular science
Full understanding of cardiovascular anatomy, pathology and physiology
Full understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
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
Must be able to work in a team environment, including inter-departmental teams and key contact representing
the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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 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 15,000 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.