Senior Manager, Clinical Project Management

Edwards Lifesciences • Irvine, CO

10d • $139,000 - $196,000

About The Position

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: Lead a clinical trial program focused on treatments for pediatric pulmonary valve disorders. 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 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

Requirements

• Bachelor's Degree in related field, with 10 years experience of previous related experience or equivalent work experience based on Edwards criteria Required or Master's Degree or equivalent in related field, with 8 years experience of previous related experience or equivalent work experience based on Edwards criteria Preferred
• Travel up to 30% nationwide

Nice To Haves

• Structural heart experience, specifically pediatric pulmonic valve disorders
• Clinical trial experience
• Experience working in a large manufacturing company or equivalent work experience based on Edwards criteria Preferred
• Certification in related discipline Preferred
• 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

Responsibilities

• Lead a clinical trial program focused on treatments for pediatric pulmonary valve disorders.
• 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 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

Benefits

• 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.

What This Job Offers

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