Senior Manager, Clinical Trial Management, (Remote) - Transcatheter Mitral and Tricuspid Therapies (TMTT)“Helping patients is our life’s work, and your contributions directly impact our ability to transform patient care around the world.” – Michael A. Mussallem, Chairman and CEOHave you been searching for a leadership role that brings you to the forefront of innovation? We have an outstanding leadership opportunity for you to join an early-stage medical device team boldly designing transcatheter mitral and tricuspid therapies from the ground up!Transcatheter Mitral and Tricuspid Therapies (TMTT) is passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast paced, dynamic team - and play a pivotal role in managing Edwards Lifesciences sponsored clinical studies, bringing new medical devices from concept to commercialization.As the Senior Manager, Clinical Trial Management / Clinical Project Management, you will lead a team of clinical research professionals and be responsible for clinical trial management of multiple studies.Flexibility to hire Remote, Hybrid, or Irvine based
Depending on experience, willing to consider candidates at Manager level
Responsibilities include, but not limited to:Manage clinical research professionals and oversee the work of multiple clinical study projects. May indirectly manage cross functional or matrix teams as appropriate.
Develop a robust talent development plan in alignment with functional growth strategies of the department
Develop and execute clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for complex clinical trials through experienced team members in accordance with GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s) and projects.
Provide direction, guidance, and oversight of cross-functional clinical research teams to execute larger or more complex projects and initiatives. Determine and seek approval for needed clinical trial resources for key projects.
Provide project status updates with formal communication to both internal and external partners. In collaboration with cross-functional partners create and deliver presentation content both internally (including executives) and externally.
Proactively analyze trial performance for opportunities for improvement. Identify and communicate study risks; recommend mitigation strategies and alternative solutions; and upon leadership alignment lead in the implementation of corrective actions in collaboration with cross functional and/or matrix teams.
Minimum Requirements:Bachelor's Degree
Minimum of 10 years of medical device/sponsor/pharmaceutical/biotech/CRO industry work experience in clinical trial management, requiredFor Manager level position, minimum of 8 years of industry experience
Minimum of 2-5 years of people management experience, requiredFor Manager level, in lieu of people management experience- willing to consider project lead experience
Ability to travel up to 25% for meetings/conferencesIn addition, for non-local applicants, the role will require travel to the Irvine headquarters every 4-6 weeks
Covid vaccination requirement
Preferred Qualifications- in addition to meeting minimum requirements, it would be nice to have the following:Experience with structural heart therapeutic area, is a plus
Experience with large scale pivotal trials, study start-up to closure, is a plus
Knowledge of Cardiovascular Physiology and structural heart anatomy is a strong preference
Prior clinical research experience with Class III Medical Devices including PMA, IDE, 510k is a strong preference
Additional Skills:Demonstrated ability to manage a team while inspiring, creating an inclusive environment and coaching team with continuous feedback
Excellent written and verbal communication, presentation, relationship management and negotiation skills
Demonstrated ability to develop clinician, research personnel, peer, cross functional and cross business unit relationships to maximize best practice sharing and optimize processes
Proven successful project management leadership skills that drive continuous evolution while maintaining strict attention to detail
Ability to interact professionally and effectively with clinicians, hospital research personnel and internally with all organizational levels including proactively escalate issues to appropriate levels of management in the organization
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Ability to work and excel within a fast-paced, dynamic, and continuously changing work environment while demonstrating a sense of urgency
Ability to proactively develop and communicate key metrics for deliverables to inform and guide decision making
Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
Expert knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols while addressing issues with impact beyond own team based on knowledge of related disciplines
Expert understanding of regulatory submissions, reporting, and audits
Knowledge of financial mechanism that relates to clinical trials
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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
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 $135,000 to $157,000.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 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.Full-time