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
10 years experience of previous related experience or equivalent work experience based on Edwards criteria Required
Master's Degree or equivalent in related field, 8 years experience of previous related experience or equivalent work experience based on Edwards criteria Preferred
Structural heart experience, specifically pulmonary 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
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

Benefits

Competitive salaries
Performance-based incentives
Wide variety of benefits programs

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementproject managementregulatory complianceGCPclinical project planningrisk managementdata analysisvendor selectionstudy site managementstructural heart experience

Soft Skills

leadershipmentoringcommunicationinterpersonal skillsnegotiationrelationship managementattention to detailproblem-solvingprioritizationdiscretion

Certifications

clinical trial certification