Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Aortic stenosis and aortic regurgitation impact millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
We are seeking a Manager of Clinical Research Monitoring to join the Edwards Pulmonic Field Monitoring team. In this pivotal role, you will be responsible for ensuring patient safety by overseeing the ethical conduct of clinical trials, maintaining strict regulatory compliance, and ensuring data integrity and protocol adherence. You will also provide strategic leadership and expert guidance on the direction and execution of clinical monitoring activities.
How you'll make an impact:
Provide input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
Participate and contribute to the development of Provide input on clinical protocols, and informed consent forms, and case report forms
Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities Act as a mentor to new or junior level employees
Provide direction and guidance to execute project deliverables in collaboration with project managers
Identify and evaluate clinical process improvement opportunities
Oversee clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence
Participate in development and validation of case report forms
Review monitoring visit reports
Resolve complex trial/study data and regulatory documentation discrepancies escalated by junior level employees
Review and complete checklist on informed consent forms (ICF)
Other incidental duties
What you'll need (Required):
Bachelor's Degree in related field
8 years of field-based clinical research monitoring experience, with a strong emphasis on quality assurance, quality control, and adherence to regulatory compliance standards
Ability to travel up to 75% for clinical site visits
Covid Vaccination
What else we look for (Preferred):
Knowledge of cardiovascular physiology and structural heart anatomy
Previous medical device Clinical Research experience in cardiology
Work with sites to deliver exceptional, prompt, and premium, monitoring services to improve compliance and quality standards
Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification)
Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k)
Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software
For California (CA), the base pay range for this position is $123,000 to $160,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.