Imagine how your ideas and expertise can change a patients 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 youll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients 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 youll make an impact:
Professional Education Proctor Governance & Logistics
Lead projects focused onProctor Governance.
Ensureaccurate and complete documentationof proctor training and certification.
Oversee theend-to-end logisticsof proctor participation in procedures:
Build and maintain aProctor Logistics Dashboard ensuring data accuracy and visibility.
Manage proctor travel arrangements and maintain full documentation aligned with internal compliance standards.
Develop a solid understanding of theproduct portfolioandclinical procedures.
2. Clinical Research Support
Provide operational support forclinical research activities
Track and follow up onmilestones for all active clinical studies ensuring proper progress and payment execution.
Manage approval workflows maintain documentation and supportback-office operationsfor multiple ongoing studies.
Follow up withEthics Committeeson protocol approvals and required submissions.
Supportsite visits including coordination for Advanced Technologies (Outflow) studies.
What youll need
Understanding ofclinical procedure workflows.
Bachelors degree in ahealth-related field(e.g. Biomedical Engineering Biomedicine Nursing or related).
Previouscorporate experience.
Foundational understanding ofclinical research.
Intermediate English(reading and writing).
Strong soft skills:
Organization
Teamwork
Clear communication
What else will help you:
Demonstrated problem-solving and critical thinking skills
Proven expertise in MS Office Suite including Word Excel Adobe and ability to operate general computer software and office machinery
Strong understanding of cardiovascular anatomy pathology and physiology or Business Unit area of expertise
Understanding of medical device regulatory requirements and documents device accountability and adverse events reporting
Technical writing skills (protocols CRF development study tools)
Ability to communicate and relate well with key opinion leaders and clinical personnel
Experience in training new hires
Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) 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
Required Experience:
Junior IC
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more