This is an exciting opportunity for you to join a team boldly designing transcatheter mitral and tricuspid therapies from the ground up. Edwards’ Transcatheter Mitral and Tricuspid Therapies (TMTT) team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives around the world.
This is a unique opportunity to play a critical role in Transcatheter Mitral & Tricuspid Therapies (TMTT) clinical study execution. The Senior Manager of Clinical Compliance for Transcatheter Mitral & Tricuspid Therapies (TMTT) will lead the Clinical Compliance team to maintain and drive high levels of accuracy and compliance in a fast-paced, complex environment. This position is located in Irvine, CA (Orange County, Southern California)
Lead TMTT Clinical Compliance team responsible for driving and ensuring study compliance in accordance with regulations and corporate processes.
Responsible for all clinical aspects of regulatory and non-regulatory audits (e.g., conducting training, identifying SMEs, ensuring the collection of required documentation.)
Lead assessment of teams’ compliance to GSOPs, work instructions, protocols, LMS and regulatory requirements.
Train and evaluate team members in conducting clinical site, vendor and internal assessments.
Strategically develop and lead the delivery of training programs for Clinical Affairs on best practices, trends, regulatory requirements and published guidance, policy and procedure updates, etc.
Lead the development, implementation and revisions of Clinical Affairs training matrices.
Review and contribute to the development of clinical protocols, CRFs, Clinical Study Reports and other clinical documents.
Manage, leverage and communicate detailed metrics reporting including study compliance and employee training dashboards to drive study compliance.
Lead audit preparation efforts for TMTT including team education, process development, timeline management, communication and implementation.
Assess, manage and ensure the resolution of audit findings and protocol deviations while developing priorities and strategies to drive compliance.
Lead the development, continuous improvement and streamlining of processes and procedures to ensure efficiency and accuracy in accordance with regulatory and company requirements.
Maintain regular contact and collaborate with partner TMTT clinical teams, cross BU partners, consultants, customers and network appropriately with relevant stakeholders.
Ensure on time execution of all deliverables in accordance with global clinical processes, regulations and good clinical practices.
Travel up to 25% US Domestic.
A bachelor's degree in a scientific or related discipline required.
Minimum of 12 years of related experience in the area of Clinical Compliance, Clinical Monitoring, Regulatory Compliance or Quality Assurance/Control.
Requires a broad cross-disciplinary and in-depth knowledge of the clinical profession.
The ideal candidate will be a dynamic leader and team player who has successfully managed a clinical compliance team in cardiovascular /medical device products.
Ability to effectively lead and manage a diverse team with successful experience supervising subordinates.
Strong leadership skills and ability to influence change.
Understand how to work effectively in a matrix organization.
Proven detailed project management experience.
Experience in clinical and regulatory aspects of medical device technology.
An advanced degree in a related discipline and/or Professional Health Science certification or designation.
Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas preferred.
Experience with Class II & III medical devices preferred.
Extensive knowledge of international regulations of Good Clinical Practice (GCP) and experience with Class II & III medical devices preferred.
Additional Talents and General Expectations:
Meticulous organizational skills and the ability to meet tight deadlines in an environment of competing priorities.
Develops strong relationships with both internal and external customers.
Demonstrates strong problem-solving, process improvement, analytical, and collaborative skills.
Proven ability to organize, analyze, and present data and relate findings to business solutions.
Comprehensive written and verbal communication, facilitation, presentation and follow-up skills.
Computer skills – CTMS, Veeva and Microsoft Word. Advanced Microsoft Excel and PowerPoint skills are required.
Extensive knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices (e.g., 21 CFR Part 11/50/54/56/ 801/803/806/807/820/812/814/821/822, ISO 14155; ICH GCPs)
Extensive knowledge and understanding of regulatory requirements for new products or product changes.
Extensive knowledge of clinical trials and quality systems (e.g., root cause analysis, trend analysis, and CAPA)
Internal Number: 014446
About Edwards Lifesciences
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 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.