Job description
Clinical Affairs Manager (Hybrid, Irvine)- Critical Care (CC)For over 40 years, Edwards Lifesciences Critical Care technologies have been helping clinicians make proactive clinical decisions to advance the care of surgical and critical care patients.
Through continuing collaboration with our clinicians, ongoing education, and our never-ending quest for innovation, Edwards continues to develop hemodynamic management solutions that enable clinicians to provide better care to patients in the OR, ICU, and ED settings.
As the Clinical Affairs Manager , you will be responsible for providing leadership to a team of clinical research professionals and clinical expertise in support of new product development and/or marketed products. This is a hybrid position located at our Irvine headquarters, some days are office-based, and some days can be worked from home.
- Comprehensive relocation packages available
- Depending on relative work experience, willing to consider candidates at a Senior Trial Manager level
Plan clinical affairs projects and activities with accountability for successful completion within scope of project deliverables
Provide clinical expertise including establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems and reports/data presentations/publications
Identify and evaluate clinical affairs process improvements and/or course correction/course alignment opportunities
Initiate, develop and maintain liaison among physicians/investigators, other medical professionals, Contract Research Organizations (CRO's), hospitals and research institutions to manage clinical trials/registries from initiation through completion
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 marking and Canadian regulatory submissions
Other incidental duties
Minimum Requirements:
Bachelor's Degree in scientific or related field, with 8 years of clinical research related experience, required OR
Master's Degree or equivalent in related field, with 6 years of clinical research related experience, required
Minimum of 1-2 years of direct people management experience, required
Ability to travel up to 10%- 20% for project needs, conferences, or clinical site monitor visits, required
Covid vaccination, required
Preferred Qualifications:
Prior clinical research experience with Class III Medical Devices including PMA, IDE, 510k is a strong preference
Experience with large scale pivotal trials, study start-up to closure, is a plus
Experience working in a large manufacturing company, especially medical device
Additional skills:
Proven expertise in both Microsoft Office Suite, including advanced Excel
Experience with CTMS and electronic document management systems a definite plus
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Ability to perform in a diverse cross-functional team environment and have ability to converse effectively with all levels of employees, management, and customers
Comprehensive record of delivering research information which adds value to management decision making process
Demonstrated ability to understand and comply with all current applicable regulations including 21 CFR 812, Canadian Medical Device Regulation (CMDR), EU Medical Device Regulation 2017/745, ISO 13485, ISO 14155:2020, Good Clinical Practice(GCP) and Company operating procedures, processes, policies, and tasks
Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
Extensive understanding of cross-disciplinary and knowledge of the clinical profession
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 competing priorities in a fast-paced environment
Ability to represent leadership on sections of projects within a specific area interfacing with project managers and cross-functional teams
Ability to consult in project setting
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $111,000 to $150,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
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 13,000 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.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
offroadmanagementgroup.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, offroadmanagementgroup.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, offroadmanagementgroup.com is the ideal place to find your next job.