Job description

Manager, Clinical Trial Management (Hybrid, Irvine)- Advanced Technologies (AT)

An exciting opportunity with Edwards' Advanced Technologies team currently involved in new cutting edge products and processes. In this innovative team you will be responsible for providing clinical expertise in support of new product development and/or marketed products. This position leverages applied research, design and development experience in new medical device and product development. As a Manager, Clinical Trial Management, you provide leadership 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.

Key Responsibilities

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, 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 marked and Canadian regulatory submissions.

Minimum Qualifications / Required Education and Experience

Master's Degree in a scientific or related field and 6 years of medical device/pharmaceutical/biotech/CRO study management experience managing complex clinical studies, preferably early feasibility studies OR

Bachelor's Degree in scientific or related field and 8 years experience as listed above

Ability to travel up to 30% domestically for site visits, quarterly visits to Irvine headquarter, conferences, and investigator meetings as needed

Preferred Qualifications In addition to meeting minimum requirements, it would be nice to have the following:

Sponsor related experience in full cycle Clinical Study Execution, including Clinical Research Monitoring and Clinical Site Management of Investigative sites.

Knowledge of cardiovascular physiology and structural heart anatomy

Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k)

Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas

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.

The base pay range for this position is $111,000 to $158,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., geographic location, 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.
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