Edwards Lifesciences: Clinical Core Labs Analyst - Transcatheter Heart Valve Unit - Irvine Campus

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

This is a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease.The Clinical Core Labs Analyst provides project management of dynamic and high volume core lab projects across all THV global clinical studies. This is done to ensure accurate and timely transfer of images from study sites to Independent Core Labs, and clinical data from Independent Core Labs to Edwards' data management teams to ultimately provide un-biased study results.Key Responsibilities: Analyze clinical output of moderately complex studies and provide high level summary with supporting details of study trial status (e.G., Core Lab image perspective) to stakeholders and clinical management 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., open information requests, aging issues, status of image analysis from Core Labs to study database, etc.) Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.G., clinical site through Image workflow vendor to Independent Core Lab) 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 Assist in the development of training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff Other incidental duties assigned by LeadershipEducation and Experience:Bachelor's Degree in related field, 3 years experience of previous hands-on clinical research related experience RequiredAdditional Skills: Good computer skills in usage of MS Office Suite including MS Project and excellent Excel skills required Excellent written and verbal communication skills and interpersonal relationship skills Solid understanding and knowledge of principles, theories, and concepts relevant to clinical trial management Solid knowledge of human anatomy and physiology Good problem-solving, organizational, analytical and critical thinking skills 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 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/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences, Irvine , Edwards Lifesciences: Clinical Core Labs Analyst - Transcatheter Heart Valve Unit - Irvine Campus, Other , Irvine, California