Senior Manager, Clinical Project Management, Trial Management, TMTT
Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: June 25, 2022
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Job Description:
Senior Manager, Clinical Project Management-Trial Management,
Transcatheter Mitral and Tricuspid Therapies (TMTT) This is an
exciting opportunity for you to join a team boldly designing
transcatheter mitral and tricuspid therapies from the ground up.
Edwards' Transcatheter Mitral and Tricuspid Therapies team is
deeply dedicated to solving the complex challenges of mitral and
tricuspid disease in order to transform treatment and significantly
improve patients' lives around the world. 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. The Senior
Manager, Clinical Project Management, will be responsible for
clinical trial management of multiple studies and may be subject
matter expert for assigned clinical studies including the planning,
implementation, oversight, project management and completion of
clinical trial. This position will be onsite located in Irvine, CA,
with up to 25% of travel. Responsibilities include, but not limited
to: Manage and oversee the work of team and 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 manage clinical project
plans to identify and complete clinical trial milestones with
accountability for successful completion of all project
deliverables for larger or more complex clinical trials through
experienced team members 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 larger or more complex projects and
initiatives. Determine clinical trial resources and set priorities
for projects Manage project status and appropriate communication
both internally and externally. May present trial information at
executive and/or industry conferences Analyze trial performance to
plan and develop corrective actions. Identify and communicate study
risks, recommend and lead in the implementation of mitigation
strategies in alignment with management Oversee the selection of
clinical vendors and study sites Other incidental duties Minimum
Education and Experience: Bachelor's Degree with related work
experience in clinical trial management, OR Master's Degree or
equivalent in in related field Demonstrated track record in people
management required Experience working in a large manufacturing
company Preferred Additional Skills: Proven successful project
management skills Proven expertise in usage of MS Office Suite and
Clinical Systems such as CTMS (Clinical Trial Management System),
eTMF (electronic Trial Master file) preferred Excellent
problem-solving, organizational, analytical and critical thinking
skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal
relationship skills including negotiating and relationship
management skills with ability to drive achievement of objectives
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
Demonstrated ability to manage assigned team and provide coaching
and feedback, including responsibility for all employee actions
including hire/fire authority and partnering with HR on all aspects
of employee relations Ability to develop and integrate metrics into
the projects and operations that clearly demonstrate the value of
clinical trials to the business Strict attention to detail Ability
to interact professionally with all organizational levels and
proactively escalate issues to appropriate levels of management in
the organization Ability to work and excel within a fast paced,
dynamic, and constantly changing work environment Frequently
interacts with customers, and/or functional peer group managers,
normally involving matters between cross-functional teams and the
company; often leads a cooperative effort among members of a
project team Participate and present at meetings with internal and
external representatives Resolve operational and scheduling issues
Dedicated to quality client service and pro-active and responsive
to client needs. Develop peer, cross functional and cross business
relationships to maximize best practice sharing and team
effectiveness. Develop relationships and leverage them to influence
change Support and solicit input from team members at all levels
within the organization 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/benefits
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.
Keywords: Edwards Lifesciences Gruppe, Irvine , Senior Manager, Clinical Project Management, Trial Management, TMTT, Executive , Irvine, California
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