Edwards Lifesciences Sr Spec, Clinical Research (REMOTE) - THV in Irvine, California
Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) Clinical Research group, focused on developing solutions for patients suffering from structural heart disease.
The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man and early feasibility through post market surveillance, leading clinical evidence in THV worldwide.
This is a great opportunity for someone who has clinical trial experience to grow their career within our Clinical Project Management group. In this role you will partner with a Clinical Project Manager to execute clinical trials for new products.
You will work with the team to ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements
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 meetingsPrepare materials for steering and investigator meetings
T his role will be working out of our Irvine, CA HQs we are open to considering remote employees who are able to work during core business hours 8am-5pm PT.
Bachelor's Degree and 5 years’ of previous experience with regulatory documentation for clinical studies
Previous experience monitoring clinical trials and or with study start up
Experience working in a large medical device company
Experience with class III devices, specifically in the structural heart space
Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)
• 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
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 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.