Clinical Research Operations Manager - Edwards Lifesciences
Irvine, CA
About the Job
Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.
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.
As the Clinical Operations Manager in Advanced Technology (AT), you’ll be responsible for managing clinical related activities to provide a platform for study success. Please note – the position is a subject matter expert (SME) role and will not have any people management duties. This role is on-site at our Irvine headquarter full time 4 days with 1 WFH day/week.
How you'll make an impact:
+ Lead clinical operation projects including quarterly audits, annual vendor reviews, etc. to support clinical studies and business initiatives
+ Oversee device management activities to ensure devices are shipped in a timely fashion for every case
+ Oversee trial training documents to ensure that we’re aligned with training matrix(es) and company SOPs
+ Monitors for the overall completeness and inspection readiness of the clinical trial master files
+ Provide guidance, mentorship and oversight to more junior clinical operations staff members
+ Manage the timely execution of key study milestones through management of performance metrics, to ensure effectiveness, LMS compliance, and TMF quality
+ Plan, oversee, and lead in the development of procedures and supportive training materials (e.g., work instructions, forms, templates and operational processes) that implement clinical process improvement
+ Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues in collaboration with cross functional and/or matrix teams
+ Facilitate the creation of training materials related to the planning and conduct of the trial for the internal research team. Conduct training for internal staff and coordinate and present at department team meetings
What you'll need (Required):
+ Bachelor’s Degree in related field PLUS 8 years of relevant clinical trial operations/clinical research/clinical monitoring experience
What else we look for (Preferred):
+ Experience working in the medical device industry
+ 1-2 years of project management leadership experience
+ Proven expertise in Microsoft Office Suite and related clinical tools and systems (e.g., Veeva, CTMS, RAVE)
+ Extensive understanding of clinical studies procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
+ Excellent written and verbal communications skills, including negotiating and relationship management skills
+ Excellent interpersonal skills
+ Excellent critical thinking and problem solving skills
+ Ability to travel up to 15%
+ Ability to work on-site 4 days and 1 WFH day/week
+ Covid-19 vaccination
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 $115,000 to $150,000 (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 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.
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.
As the Clinical Operations Manager in Advanced Technology (AT), you’ll be responsible for managing clinical related activities to provide a platform for study success. Please note – the position is a subject matter expert (SME) role and will not have any people management duties. This role is on-site at our Irvine headquarter full time 4 days with 1 WFH day/week.
How you'll make an impact:
+ Lead clinical operation projects including quarterly audits, annual vendor reviews, etc. to support clinical studies and business initiatives
+ Oversee device management activities to ensure devices are shipped in a timely fashion for every case
+ Oversee trial training documents to ensure that we’re aligned with training matrix(es) and company SOPs
+ Monitors for the overall completeness and inspection readiness of the clinical trial master files
+ Provide guidance, mentorship and oversight to more junior clinical operations staff members
+ Manage the timely execution of key study milestones through management of performance metrics, to ensure effectiveness, LMS compliance, and TMF quality
+ Plan, oversee, and lead in the development of procedures and supportive training materials (e.g., work instructions, forms, templates and operational processes) that implement clinical process improvement
+ Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues in collaboration with cross functional and/or matrix teams
+ Facilitate the creation of training materials related to the planning and conduct of the trial for the internal research team. Conduct training for internal staff and coordinate and present at department team meetings
What you'll need (Required):
+ Bachelor’s Degree in related field PLUS 8 years of relevant clinical trial operations/clinical research/clinical monitoring experience
What else we look for (Preferred):
+ Experience working in the medical device industry
+ 1-2 years of project management leadership experience
+ Proven expertise in Microsoft Office Suite and related clinical tools and systems (e.g., Veeva, CTMS, RAVE)
+ Extensive understanding of clinical studies procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
+ Excellent written and verbal communications skills, including negotiating and relationship management skills
+ Excellent interpersonal skills
+ Excellent critical thinking and problem solving skills
+ Ability to travel up to 15%
+ Ability to work on-site 4 days and 1 WFH day/week
+ Covid-19 vaccination
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 $115,000 to $150,000 (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 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.
Source : Edwards Lifesciences