Senior Manager, Clinical Program Management (THV)

11 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 take our patient-focused innovations to improve the quality of our patient’s lives.As a Senior Manager, Clinical Program Management, you will manage clinical trial activities in accordance with all applicable regulatory requirements In this role, you will be accountable for key study deliverables, including site selection, training, site activation, patient enrollment, data collection and review, compliance, and support of key regulatory submissions and product development core teams. This role puts strong emphasis on agility, strategic thinking, complex problem-solving and ability to influence others to drive results.Key ResponsibilitiesDevelop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for high-profile and 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 projects for multiple clinical studies and initiatives on schedule and within budget

Determine clinical trial resources, develop enrollment and budget forecasts, and set priorities for projects

Manage project status and appropriate communication both internally and externally including key opinion leaders

Present trial information at executive and/or industry conferences

Analyze trial performance to plan and develop corrective actions

Anticipate and communicate study risks and lead in the implementation of mitigation strategies

Build an effective and efficient clinical project team

Provide mentoring and coaching to other project team members

Oversee the selection of clinical vendors and study sites

Manage and oversee the preparation of clinical portions of IDE and PMA submissions

Minimum RequirementsBachelor’s degree with 12 years of previous related experience including medical device, pharmaceutical, biotech and/or CRO industry experience inclusive of study management experience managing complex clinical studies OR

Master’s degree or equivalent with 10 years of previous related experience as listed above

Experience working in a large manufacturing company

Ability to travel up to 20% for conferences and site visits

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 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: #22586154
  • State: California Irvine 92602 Irvine USA
  • City: Irvine
  • Salary: USD TBD TBD
  • Showed: 2021-11-11
  • Deadline: 2022-01-11
  • Category: Et cetera