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Analyst, Clinical Device Management – Transcatheter Mitral and
Category: Health Care Industry
  • Your pay will be discussed at your interview

Job code: lhw-e0-88631171

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Edwards Lifesciences

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  Job posted:   Sun Apr 22, 2018
  Distance to work:   ? miles
  1 Views, 0 Applications  
Analyst, Clinical Device Management – Transcatheter Mitral and
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 (TMTT) 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.

The Analyst, Clinical Device Management will develop device processes associated with clinical trials. Ensure compliance with regulations and manage the lifecycle of devices.

**Essential Job Functions:**

+ Analyze clinical device data and notify cross functional team members (e.g., CRA, CS, and/or site coordinator) for data updates/changes

+ Partner with Quality to resolve device related issues

+ Identify technical and data issues and collaborate with appropriate team members to bring to resolution; Assist in the determination of root cause and recommend and implement corrective actions

+ Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., device return aging issues, status of open device issues/queries, etc.)

+ Develop training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff

+ Provide training on device accountability process within electronic database (e.g., SalesForce) for cross functional team members (e.g., clinical specialist and field monitors)

+ Compile and analyze accurate date of regulatory reports for submission for the regulatory bodies (e.g., FDA)

+ Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.g., transition to new device system, system enhancements, etc.) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines

+ Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables

+ Travel between 10%-20% within United States for training clinical sites

+ Other incidental duties assigned by Leadership



**Required Education/Skills/Experience:**

+ Bachelor's Degree in related field

+ 3 years of previous clinical trial management experience

+ Will consider Associate's Degree with 5 years related experience

**Additional Talents and General Expectations:**

+ Proven expertise in Microsoft Office Suite, including Excel, JDE, electronic database (e.g., Salesforce) required

+ Good written and verbal communication skills and interpersonal relationship skills

+ Demonstrated problem-solving and critical thinking skills

+ Moderate understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management

+ Moderate understanding and knowledge of clinical device accountability

+ Moderate problem-solving, organizational, analytical and critical thinking skills

+ Moderate understanding of regulatory requirements (e.g., CFR, GCP) and documents

+ Moderate knowledge in Microsoft Office Suite, including Excel, JDE, electronic database (e.g., Salesforce) required

+ Good written and verbal communications skills

+ Moderate problem-solving skills

+ Ability to manage confidential information with discretion

+ Strict attention to detail

+ Ability to interact professionally with all organizational levels

+ Ability to manage competing priorities in a fast paced environment

+ Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

+ Ability to build productive internal/external working relationships

+ Adhere to all EHS rules and requirements 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

About Edwards

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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.

Title: Analyst, Clinical Device Management - Transcatheter Mitral and Tricuspid Therapies
Location: USA-USA-California - Irvine
Job Number: 013778

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