Edwards Lifesciences Senior Specialist, Clinical Research - Surgical Structural Heart, Irvine Location in Irvine, California
Edwards Lifesciences Surgical Structural Heart division has a unique opportunity for a Senior Specialist Clinical Research to join our team, to ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.
This role is located in and based out of Irvine, CA
• Responsible for study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing and communicating the status of study progress and activities
• Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution. Oversee the work of the Sr Representative and may provide coaching and training to lower level employees
• Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
• Lead in assessing current and new processes, identifying opportunities and implementing solutions to improve process efficiency within and across related functional areas
• Conduct in-house and site (if applicable) reviews of associated documentation and lead in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure documents are compliant with Good Documentation Practices and Edwards internal SOPs, and US and OUS regulations
• Partner with clinical project manager in leading regular team meetings
• Prepare materials for steering and investigator meetings
• Other incidental duties
Education and Experience:
Bachelor's Degree, 5 years of experience with regulatory documentation for clinical studies required.
• Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
• Excellent written and verbal communication skills and interpersonal relationship skills
• Excellent problem-solving and critical thinking skills
• Full knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
• Full understanding of regulatory submissions, reporting, and audits
• 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
• Travel up to 50%
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.