Senior Manager, Clinical Project Management - Edwards Lifesciences
Sacramento, CA
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.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As the Senior Manager of Clinical Project Management, you will manage complex clinical trials activities and ensure all applicable regulatory requirements are met.
- Flexibility to hire Remote, Hybrid, or Irvine based
You will make an impact by...
• Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for larger or more complex clinical trials in accordance to GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s)
• Provide direction, guidance, and oversight of clinical core teams to execute larger or more complex projects and initiatives. Determine clinical trial resources and set priorities for projects
• Manage project status and appropriate communication both internally and externally. May present trial information at executive and/or industry conferences
• Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in alignment with management
• Provide mentoring and coaching to other project team members
• Oversee the selection of clinical vendors and study sites
• Other incidental duties
What you'll need (Required):
+ Bachelor's Degree in related field
+ 10 years' experience of industry medical device/sponsor/pharmaceutical/CRO, work experience in clinical trial management OR
+ Masters Degree with 8 years of industry medical device/sponsor/pharmaceutical/CRO clinical trial management experience
+ Ability to travel up to 20% for meetings, conferences, clinical site visits
+ *For non-local applicants, role will require travel to Irvine headquarters every 4-6 week
+ Covid Vaccination
What else we look for (Preferred):
• Experience with structural heart therapeutic area
• Study management experience managing complex clinical studies, preferably early feasibility studies
• Prior clinical research experience with Class III Medical Devices including PMA, IDE, 510k is a strong preference
• Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file), Microsoft Project
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Recognized as an expert in own area with specialized depth within the organization
• Expert knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
• Expert understanding of regulatory submissions, reporting, and audits
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on projects within a specific area interfacing with project managers and clinical team
• Consult in project setting within specific area
• Provides leadership to outsourcing partners on a task level, and may participate on small scale RFP
• 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 $123,000 to $174,000 (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 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.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As the Senior Manager of Clinical Project Management, you will manage complex clinical trials activities and ensure all applicable regulatory requirements are met.
- Flexibility to hire Remote, Hybrid, or Irvine based
You will make an impact by...
• Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for larger or more complex clinical trials in accordance to GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s)
• Provide direction, guidance, and oversight of clinical core teams to execute larger or more complex projects and initiatives. Determine clinical trial resources and set priorities for projects
• Manage project status and appropriate communication both internally and externally. May present trial information at executive and/or industry conferences
• Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in alignment with management
• Provide mentoring and coaching to other project team members
• Oversee the selection of clinical vendors and study sites
• Other incidental duties
What you'll need (Required):
+ Bachelor's Degree in related field
+ 10 years' experience of industry medical device/sponsor/pharmaceutical/CRO, work experience in clinical trial management OR
+ Masters Degree with 8 years of industry medical device/sponsor/pharmaceutical/CRO clinical trial management experience
+ Ability to travel up to 20% for meetings, conferences, clinical site visits
+ *For non-local applicants, role will require travel to Irvine headquarters every 4-6 week
+ Covid Vaccination
What else we look for (Preferred):
• Experience with structural heart therapeutic area
• Study management experience managing complex clinical studies, preferably early feasibility studies
• Prior clinical research experience with Class III Medical Devices including PMA, IDE, 510k is a strong preference
• Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file), Microsoft Project
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Recognized as an expert in own area with specialized depth within the organization
• Expert knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
• Expert understanding of regulatory submissions, reporting, and audits
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on projects within a specific area interfacing with project managers and clinical team
• Consult in project setting within specific area
• Provides leadership to outsourcing partners on a task level, and may participate on small scale RFP
• 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 $123,000 to $174,000 (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 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