Associate Manager, Clinical Project Management (Irvine, CA), Transcatheter Heart Valves (THV)
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. Through clinical evidence we are able to take our patient-focused innovations to improve the quality of our patient’s lives.
As an Associate Manager, Clinical Project Management, you manage clinical trial activities and ensure all applicable regulatory requirements are met. This is an individual contributor, subject matter expert role based in Irvine, California OR remotely within the United States. Full relocation package provided.
Essential Job Functions/Key Responsibilities
- 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
- Bachelor’s degree with 8 years of medical device, pharmaceutical, biotech and/or CRO industry experience inclusive of study management experience managing complex clinical studies
- Minimum one year of direct project management experience
- Experience working in a large manufacturing company
Preferred Qualifications In addition to meeting minimum requirements, it would be nice to have the following:
- Medical device project management experience
- Knowledge of Cardiovascular Physiology and structural heart anatomy is a strong preference
- Prior clinical research experience with class III medical devices including PMA, IDE, 510(k)
- Understanding of international and domestic medical device regulations and guidance
- Full understanding of regulatory submissions, reporting and audits
- PMP certification
- Microsoft Project expertise
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.