We have a unique opportunity to play a critical role in the transcatheter mitral and tricuspid valve space with new cutting edge technologies.
As the Senior Manager Clinical Affairs (Trial Management) you will oversee the development and execution of pre and post commercial global clinical trials/registries on Edwards Lifesciences products and to ensure compliance with US Food and Drug Administration (FDA) or other Regulatory agencies. The Senior Manager Clinical Affairs (Trial Management) also leads and manages Contract Research Organizations, Contract and FTE study monitors, DSMB/CEC/core labs, as well as administrative and temporary support as needed.
This role is not a field based position. Position based out of Irvine, CA
Initiate, develop and maintain liaison among physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals and research institutions to manage clinical trials/Registries from initiation through completion.
Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and reports/data presentations/publications. Manage initiation of clinical sites and study protocol training, and oversee clinical data collection, trial monitoring and auditing according to GCP guidelines and Edwards Global Policies and Standard Operating Procedures. Prepare required documentation for FDA, Canada, Japan, Europe, and other regulatory submissions, including PMA's, IDE's, 510(k) CE marked and Canadian regulatory submissions.
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.
Developing and managing budgets.
Managing and developing direct reports.
Managing projects, processes, preparation and dissemination of study data and study reports, internal and external relationships, and Consultants.
Represent the Clinical Affairs Trial Management Team during clinical trial cases with physicians, hospital staff and coordinators.
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.
A bachelor's or advanced degree in a scientific or related discipline (exceptions only for exceptional candidates or those with professional health certification or designation and commensurate experience).
Minimum of 12 years related professional experience required.
Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas.
Skill levels exceeding requirements of the Manager
Must have previous managerial experience of clinical projects and people.
Ability to travel up to 30% within U.S.
Certification in related field preferred
Other Skills and General Expectations:
Requires a broad cross-disciplinary and in-depth knowledge of the clinical research profession;
Requires a broad cross-functional team experience;
A qualified record of implementing new clinical projects;
Experience in creating and managing budgets;
Comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills;
Ability to meet deadlines on multiple projects required;
Must be able to perform in a diverse cross-functional team environment and have ability to converse effectively with all levels of employees, management, and customers;
A comprehensive record of delivering research information which adds value to management decision making process;
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;
Advanced personal computer skills including spreadsheet, word processing, database management, power point and other necessary applications preferred. Experience with CTMS systems a definite plus.
Good presentation skills; ability to present material comfortably.
Ability to establish relationships and manage communications with key clinical customers such as physicians, nurses, administrators etc. Good teamwork, communication (written/verbal) and relationship building skills.
Strong time and project management skills.
Must be proficient with computer. Must be proficient with Microsoft Office suite.
Ability to exercise independent judgment and problem-solving.
Incumbent is required to fully comply with all US and Global regulations, and SOPs in the execution of all job duties
Quick learner; ability to come up to speed quickly on Edwards’ products and services.
Ability to work positively through confrontation and/or conflicting ideas.
Direct Subordinates (planned): Study Monitors, Clinical Administrative Support, CRO and other consulting Bodies (DSMB, CEC, etc.)
Internal Number: 013823
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.