Clinical Compliance Manager - Edwards Lifesciences
Dover, DE
About the Job
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 the Clinical Compliance Manager, you will conduct audits of sites, vendors, and Clinical Affairs and provide guidance on course corrections. Please note that this role is a subject matter expert (SME) role and will not have any direct reports nor managerial duties involved.
How you’ll make an impact:
+ Lead in the evaluation of all audit findings (e.g., internal, site, vendor) from beginning to end, to determine severity, i.e., critical, major or minor, and provide advice and guidance in developing corrective and preventative course of action to resolve audit findings
+ Lead and conduct audits of (a) EW’s internal clinical processes (b) clinical sites and (c) vendor audits - including complex audits across business units and regions, budgeting, scheduling, and staffing (internal and/or CROs). Develop and execute audit plans and schedules for compliance audits of assigned clinical study projects
+ Lead continuous process improvement of efficiency and accuracy of processes and procedures. Assess and identify compliance risk based on clinical quality data of observations
+ Train and assess team members in conducting clinical site, vendor, internal audits and document performance as a basis for qualification
+ Develop and deliver training programs for clinical groups and Clinical Compliance on best practices, trends, regulatory requirements and updates and published guidance, policy and procedure updates, etc.
+ Provide guidance on Clinical Standard Operating Procedures (SOP's) to Edwards Business Units to ensure compliance with FDA regulations, GCP and ISO
+ Guide business unit representatives on clinical compliance during external audits conducted by regulatory agencies
+ Review and provide feedback on clinical protocols, CRFs, Clinical Study Reports and other clinical documents
+ Other incidental duties assigned by leadership
What you’ll need (required):
+ Bachelor’s Degree in related field
+ Minimum 7 years of previous related clinical monitoring, quality assurance/control, or regulatory compliance experience from a sponsor or CRO
+ Ability to travel up to 25% nationwide
What else we look for (preferred):
+ Experience with working in a medical device or regulated industry
+ Experience with Class III (FDA) cardiac or implantable devices
Additional skills:
+ Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
+ Excellent written and verbal communication skills and interpersonal relationship skills
+ Excellent problem-solving, organizational, analytical and critical thinking skills
+ Good 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 GCPs)
+ Good knowledge and understanding of global regulatory requirements for new products or product changes
+ Good knowledge of clinical trials and quality systems (e.g., root cause analysis, trend analysis, and CAPA)
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast paced environment
+ Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
+ 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 $115,000 to $163,000 (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.
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 the Clinical Compliance Manager, you will conduct audits of sites, vendors, and Clinical Affairs and provide guidance on course corrections. Please note that this role is a subject matter expert (SME) role and will not have any direct reports nor managerial duties involved.
How you’ll make an impact:
+ Lead in the evaluation of all audit findings (e.g., internal, site, vendor) from beginning to end, to determine severity, i.e., critical, major or minor, and provide advice and guidance in developing corrective and preventative course of action to resolve audit findings
+ Lead and conduct audits of (a) EW’s internal clinical processes (b) clinical sites and (c) vendor audits - including complex audits across business units and regions, budgeting, scheduling, and staffing (internal and/or CROs). Develop and execute audit plans and schedules for compliance audits of assigned clinical study projects
+ Lead continuous process improvement of efficiency and accuracy of processes and procedures. Assess and identify compliance risk based on clinical quality data of observations
+ Train and assess team members in conducting clinical site, vendor, internal audits and document performance as a basis for qualification
+ Develop and deliver training programs for clinical groups and Clinical Compliance on best practices, trends, regulatory requirements and updates and published guidance, policy and procedure updates, etc.
+ Provide guidance on Clinical Standard Operating Procedures (SOP's) to Edwards Business Units to ensure compliance with FDA regulations, GCP and ISO
+ Guide business unit representatives on clinical compliance during external audits conducted by regulatory agencies
+ Review and provide feedback on clinical protocols, CRFs, Clinical Study Reports and other clinical documents
+ Other incidental duties assigned by leadership
What you’ll need (required):
+ Bachelor’s Degree in related field
+ Minimum 7 years of previous related clinical monitoring, quality assurance/control, or regulatory compliance experience from a sponsor or CRO
+ Ability to travel up to 25% nationwide
What else we look for (preferred):
+ Experience with working in a medical device or regulated industry
+ Experience with Class III (FDA) cardiac or implantable devices
Additional skills:
+ Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
+ Excellent written and verbal communication skills and interpersonal relationship skills
+ Excellent problem-solving, organizational, analytical and critical thinking skills
+ Good 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 GCPs)
+ Good knowledge and understanding of global regulatory requirements for new products or product changes
+ Good knowledge of clinical trials and quality systems (e.g., root cause analysis, trend analysis, and CAPA)
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast paced environment
+ Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
+ 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 $115,000 to $163,000 (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.
Source : Edwards Lifesciences
