Senior Manager, Clinical Project Management, Global Clinical Research Aortic

Edwards Lifesciences • Irvine, CA

5d • $139,000 - $196,000

About The Position

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.

How you’ll make an impact:
As the Manager of Clinical Project Management THV Global Clinical Research, you will manage clinical trials activities and ensure all applicable regulatory requirements are met.
This role requires the ability to synthesize large sets of clinical trial data to support innovative operational strategies.
Experience working with long-term clinical trials, IDE and Post approval, in a matrix organization, and ability to oversight clinical core team in navigating data cleaning process for regulatory submissions is essential.
Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables in 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, gain alignment with leadership on proposals prior to implementation
Identify and communicate study risks, recommend and lead implementation of mitigation strategies in alignment with management
Oversee the selection and deliverable of clinical vendors and study sites
Provide mentoring and coaching to other project team members

Requirements

• Bachelor's Degree in related field
• 10 years experience of previous related experience or equivalent work experience based on Edwards criteria
• Experience working with long-term clinical trials, IDE and Post approval, in a matrix organization
• Ability to oversight clinical core team in navigating data cleaning process for regulatory submissions
• 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) preferred
• 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

Nice To Haves

• Master's Degree or equivalent in related field
• 8 years experience of previous related experience or equivalent work experience based on Edwards criteria
• Experience working in a large manufacturing company or equivalent work experience based on Edwards criteria
• Certification in related discipline
• Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)

Responsibilities

• Manage clinical trials activities and ensure all applicable regulatory requirements are met.
• Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables in 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, gain alignment with leadership on proposals prior to implementation.
• Identify and communicate study risks, recommend and lead implementation of mitigation strategies in alignment with management.
• Oversee the selection and deliverable of clinical vendors and study sites.
• Provide mentoring and coaching to other project team members.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior