Edwards Lifesciences TMTT division has a unique opportunity for a Manager of Clinical Affairs to be accountable for key study deliverables within timelines and budget. The Manager conduct and report studies in accordance with all applicable regulatory requirements. The candidate will be adaptable and a problem-solver with the ability to work within cross-functional teams and to evaluate and manage research studies
Responsibilities but not limited to:
Clinical Study Execution, and Clinical Site Management
Responsible for study start-up and study conduct activities including managing essential documents
Manage study milestones, including accurate tracking and reporting of study metrics
Develop and maintain liaison among physicians/investigators, other medical professionals, Research Organizations (CR0’s) hospital and research institution to manage clinical trials form initiation through completion.
Developing and conducting clinical studies/registries from initiation to completion, while ensuring study compliance and data completeness;
Maintaining appropriate regulatory documents both internally and externally;
Supporting sponsor site interaction for IRBs, contract, and training;
Managing study documentation within the CTMS and eTMF frameworks
Review of various site visit reports
Investigate and execute resolutions for discrepancies in study documentation, by applying clinical protocol knowledge and GCP guidelines and Edwards Global Policies and Standard Operating Procedures.
Managing and communicate the status of study progress and activities.
Manage of the study timelines, resources, budget, risk and quality plans
Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Director.
Creates team culture and promotes team spirit
Ensure all safety reporting of procedural and post-procedural adverse events and device-related complications are completed in accordance with regulatory and corporate/divisional requirements. Follow up with European/US Regulatory Affairs as necessary.
Ensure device accountability by tracking the location of all clinical trial devices.
Manage inventory to include par levels, expiration dates, and initiate shipments and returns of investigational products according to regulatory and company guidelines.
This role is located in Irvine, CA
Bachelor’s degree in a life science or related field with a minimum of 10 years of medical device/pharmaceutical/biotech/CRO industry experience with a minimum of 5 years of study management experience managing complex international clinical studies.
Experience of project managing operational aspects of a clinical study including timelines, budgets and resource plan Strict attention to detail
Minimum of 5 years of independent monitoring experience as a CRA managing investigator sites.
Requires a broad cross-functional team experience;
A qualified record of implementing new clinical projects;
Comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills;
Ability to meet deadlines on multiple projects required;
A demonstrated ability to understand and comply with all current applicable regulations including CFR 820, Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485, Good Clinical Practice(GCP) and Company operating procedures, processes, policies, and tasks;
Strong time and project management skills
Ability to work positively through confrontation and/or conflicting ideas.
Full understanding of regulatory submissions, reporting, and audits
Prior Medical Device Experience in heart valve disease, coronary artery disease, and peripheral vascular disease and congestive heart failure areas strongly preferred.
Full knowledge and understanding of ICH and GCP guidelines
Ability to manage confidential information with discretion
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
Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification)
Prior clinical research experience within Medical Devices including PMA, IDE
Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments.
Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization. Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. Medidata
Up to 50% travel (EU, Canada and the US)
Able to relocate or reside within a commutable distance to Irvine, CA
Internal Number: 012921
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.