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Edwards has an exciting opportunity with our Surgical Structural Heart group, focused on developing new and maintaining the best standard of surgical and minimal invasive treatments for patients suffering from heart valve disease.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 andsite 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
Additional Talents and General Expectations:Proven successful project management skills
Proficient 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
Recognized as an expert in one or more areas with broad-based advanced knowledge within the organization
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
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 $162,000 to $189,000.Additional 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 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.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