Specialist, Clinical Compliance - Transcatheter Mitral and Tricuspid Therapies (TMTT)
Company: Edwards Lifesciences
Posted on: October 12, 2018
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. **POSITION OVERVIEW:** + The Specialist of Clinical Compliance will maintain and drive high levels of accuracy and compliance in a fast-paced, complex environment. **Key Responsibilities:** + Support TMTT clinical audit preparation efforts including contributing to team education, SME identification, process development, timeline management, communication and implementation. + Support audits of internal clinical processes, clinical sites and/or vendor audits. + Identify opportunities for improvement of efficiency and accuracy of processes and procedures. Present metrics to parties audited. + Review and follow up with appropriate staff to ensure that audit findings are addressed and issues are resolved. + Support development of training presentations for Clinical Affairs teams on best practices, trends, regulatory requirements and updates and published guidance, policy and procedure updates, etc. + Conduct internal and external compliance assessments to evaluate the adherence to company standard operating procedures (SOPs), regulatory requirements, investigational study plans, regulatory documentation requirements and departmental procedures. + Evaluate TMTT Clinical Affairs LMS training plan compliance to ensure all staff stay current with training requirements. Send monthly reports to Clinical Affairs management. + Maintain regular contact with partner TMTT clinical teams and network appropriately with relevant stakeholders. + Travel up to 10% US Domestic. + This position is located in Irvine, CA. \#LI-MO1 \#AS Qualifications: **Required Education/Skills:** + A bachelor's degree with 3 years related experience required. + 1 year of previous related experience and medical device or regulated industry preferred. + Cross-functional team experience required. **Preferred Qualifications:** + Project management experience. + 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. **Additional Talents and General Expectations:** + Good knowledge of clinical trials and quality systems. + Good written and verbal communication, interpersonal, quantitative, analytical, organizational, critical thinking, problem solving and follow-up skills. + A demonstrated ability to understand and comply with all current applicable regulations, Good Clinical Practice (GCP) and company operating procedures, processes, policies and tasks. + Ability to meet deadlines on multiple projects required. + Must be able to perform in a diverse cross-functional team environment and have ability to communicate effectively with all levels of employees, management and customers. + Good computer skills including Microsoft Office Suite, CTMS and electronic document management systems preferred. About Edwards 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. Title: Specialist, Clinical Compliance ? Transcatheter Mitral and Tricuspid Therapies (TMTT)Location: USA-USA-California - IrvineJob Number: 015283
Keywords: Edwards Lifesciences, Irvine , Specialist, Clinical Compliance - Transcatheter Mitral and Tricuspid Therapies (TMTT), Healthcare , Irvine, California
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