This position supports the overall development, implementation, and continuous improvement of Clinical Compliance processes globally. As part of the Corporate Quality function, it supports all Edwards Business Units and sites, by providing leadership, coordination and advocacy in project management of systems and programs that support Edwards’ business plans and core values, in coordination with other Edwards’s associates and senior management. Accountable for decreased Clinical procedures and processes complexity, increased effectiveness, and absence of significant quality issues and regulatory actions by external agencies. Responsible for providing expertise and guidance to clinical teams on clinical regulations.
Essential Job Functions:
Identify, lead and provide business process improvement solutions for Clinical Compliance systems, including creating reviewing and approving changes to procedures and processes, to improve operation, efficiencies, and user experience.
Provide Compliance guidance to Clinical Affairs on clinical trial documents, clinical trial execution, clinical trial data and clinical regulatory requirements.
Lead complex projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing Clinical Compliance on cross-functional teams.
Develop and deliver training programs to Clinical Affairs & Clinical Compliance on best clinical practices, trends, regulatory requirements and updates and published guidance, policy and procedures.
Conduct audits of (a) EW’s internal clinical processes (b) clinical sites and (c) vendor audits.
Drive investigations of basic problems, perform robust root cause analysis, develop and implement corrective actions, and establish monitoring plans in collaboration with cross functional SMEs.
Provide technical direction to lower level staff.
Other incidental duties assigned by Leadership.
Bachelor's Degree with 10 years of previous related experience in clinical research and clinical compliance required.
Proven successful project management skills.
Proven expertise in MS Office Suite.
Excellent facilitation and presentation skills.
Excellent problem-solving, organizational, analytical and critical thinking skills.
Excellent documentation, communication skills and interpersonal relationship skills including negotiating and relationship management skills.
Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards.
Extensive understanding of medical devices regulations (e.g., FDA (21 CFR Part 11/50/54/56/812/820) ISO14155/13485, ICHs, and other applicable regulations.
Ability to maintain a working knowledge of current and proposed Clinical laws, regulations, guidelines and standards.
Ability to transfer essential knowledge and mentor other team members on specialized skills.
Strict attention to detail.
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
Ability to manage multiple projects and competing priorities in a fast-paced environment.
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, Californi...a, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.