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 impacts 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.As a Clinical Records Supervisor , you will be responsible for supervising the Clinical Records team and working on process improvements to our clinical records management process within the THV business unit.The position will be on-site at our Irvine headquarter 4 days/week with 1 WFH day.How you will make an impact:
Supervise employees and oversee the daily work activities including assessing daily progress within all aspects of the eTMF (electronic trial master file) including accuracy, completeness and compliance of documentation in multiple clinical research trials
Lead sections of improvement projects in collaboration with cross-functional teams
Provide feedback and/or conduct performance reviews on employees, including resolving performance issues. Provide training and improve training plans for assigned and/or cross-functional team(s)
Gather data via data reporting and provide basic assessment to management
Represent Clinical Records Management and provide subject matter expertise for internal and external audits including follow up corrective actions and effectiveness monitoring under some guidance from management
Lead team with production, distribution and tracking of study materials (e.g. study binders and patient recruitment materials) to clinical sites
Lead in the development, maintenance and management of internal study training matrices and tracking of respective training records
What you will need (required):
Bachelor’s degree AND 1 year of previous related experience with regulatory documentation for clinical studies from a sponsor/CRO
OR
Associate’s degree AND 4 years of previous related experience with regulatory documentation for clinical studies from a sponsor/CRO
What else we look for (preferred):
Strong leadership skills or previous people management experience
Experience with Clinical Systems (e.g., CTMS (Clinical Trial Management System), electronic Trial Master file (e.g., Veeva eTMF)
Experience with Class II & III medical devices
Additional skills:
Full responsibility for all personnel including hire/fire authority and handling all aspects of employee relations
Strong computer skills in Microsoft Office Suite
Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives
Full knowledge and understanding of Edwards policies and procedures related to assigned phase within assigned area of responsibility
Full knowledge and understanding of international regulations of Good Clinical Practice (GCP)
Full knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices (e.g., 21 CFR Part 11/50/54/56/801/803/806/807/820/812/814/821/822, ISO 14155; ICH E6)
Full knowledge of clinical trials and regulatory requirements
Full knowledge of medical terminology
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Ability to lead teams, provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Strict attention to detail
Ability to interact professionally with internal customers and cross functional teams
Ability to work in a fast paced environment
Must be able to work with cross-functional teams as well as with colleagues from other departments within immediate work area
May represent the organization to outside contacts, e.g., vendors, suppliers, contractors, staffing agencies
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 $56,000 to $80,000(highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.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 15,000 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.
