Job description

Senior Manager, Clinical Project Management, Transcatheter Heart Valve (THV) Clinical Affairs

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring, with a rapidly growing portfolio of innovative and less invasive solutions.

The Transcatheter Heart Valve (THV) clinical affairs organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.

We have an opportunity on the THV Clinical Affairs team for a Senior Manager, Clinical Project Management to manage clinical trial activities and to ensure all applicable regulatory requirements are met .

This role is based on site at Edwards Lifesciences’ corporate headquarters in Irvine, California.

Key Responsibilities:
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

Minimum Requirements:
Bachelor's Degree in related field with 10 years related experience in clinical research, including project management
Master's Degree in related field with 8 years related experience in clinical research, including project management
Doctorate Degree in related field with 6 years related experience in clinical research, including project management

Preferred Qualifications:
Experience in CV medical device clinical research, particularly in mitral valve clinical studies
Experience monitoring multiple clinical sites for IDE studies
Experience managing multiple studies in multiple stages
Experience interfacing with clinical research staff
Experience working in a large medical device company
Experience working cross-functionally
Experience reviewing and approving reports such as Annual Progress Reports, Clinical Study Reports
Experience assessing the impact of clinical study risks and provide guidance on next steps

Additional Skills and Expectations:
Proven successful project management skills
Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)
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).

About Edwards Lifesciences

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 13,000 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.

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.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

offroadmanagementgroup.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, offroadmanagementgroup.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, offroadmanagementgroup.com is the ideal place to find your next job.