Associate Manager, Project Management - THVTHV
Employment Type: Full-Time
Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease.
The THV clinical 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.
This is a great opportunity for someone who has experience as a clinical monitor or as a CRA to grow their career with our Clinical Project Management group. In this role you will partner with a Sr. Manager, CPM to execute clinical trials for new products.
You will work with the team to ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements
* Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables 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 projects and initiatives
* Manage project status and appropriate communication both internally and externally
* Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in collaboration with management
* Oversee the selection of clinical vendors and study sites
* Provide mentoring and coaching to other project team members
This role will be working out of our Irvine, CA HQs we are open to considering remote employees who are able to work during core business hours 8am-5pm PT.
* Bachelor's Degree
* 8 years of experience with regulatory documentation for clinical trials
* Previous experience monitoring clinical trials and or with study start up
* Experience working in a large medical device company
* Experience with class III devices, specifically in the structural heart space
* Previous Project Management Experience
* PMP Certification
* Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)
* Proven successful project management skills
* Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
* Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
* Extensive knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
* Extensive 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 sections of projects within a specific area interfacing with project managers and clinical team
* Consult in project setting within specific sections
* Provides leadership to outsourcing partners on a task level
* Adhere to all EHS rules and requirements 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.