Associate Manager, Clinical Project Management, Transcatheter Heart Valves (THV)

13 Nov 2024

Vacancy expired!

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 ResponsibilitiesDevelop 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

Minimum RequirementsBachelor’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

For Colorado Residents Only: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.The base pay range for this position is $117,000 to $137,000Additional information can be found through the link below:https://www.edwards.com/careers/benefitsEdwards 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 Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, 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.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Full-time
  • ID: #22691801
  • State: Maryland Remote 00000 Remote USA
  • City: Remote
  • Salary: USD TBD TBD
  • Showed: 2021-11-13
  • Deadline: 2022-01-12
  • Category: Et cetera