Senior Analyst, Clinical Patient Screening Core Labs

Edwards Lifesciences • Irvine, CA

1d • Onsite

About The Position

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Requirements

• Bachelors degree in biological sciences or Lifesciences field with 5 years of Patient screening experience in the setting of a clinical trial or equivalent work experience based on Edwards criteria
• Required Travel up to 25% nationwide

Nice To Haves

• Full knowledge and understanding of policies, procedures, and guidelines relevant to clinical studies
• Full understanding of medical terminology as it relates to clinical studies
• Excellent computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint and related system(s)
• Excellent written and verbal communication skills and interpersonal relationship skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Good leadership skills
• Ability to manage confidential information with discretion
• Strict attention to details
• Ability to interact professionally with all organizational levels
• Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• 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

Responsibilities

• Provide recommendations and insights on the development and implementation of core lab screening/FU strategy and provide guidance from functional standpoint on strategy execution.
• Develop methodologies based on core lab infrastructures and trial needs.
• Create tools and materials needed for success of echo quality from screening through follow up for sites from core lab.
• Drives process' for trial needs overall (i.e. CRF redlining, data snap, sci comm reviews, data collection and monitoring).
• Develop and implement clinical and pre-clinical core lab data pulls process.
• Leads monitoring activities for core lab (i.e. monitoring initiation letter, meetings with core lab during monitoring visit, closing letter, monitoring report).
• Conducts all communication to core lab, including KOLs, for monitoring activities.
• Provide knowledge transfer to team members on how to prioritize core lab management tasks per business needs and to maintain relationships core lab KOLS.
• Leads the coordination of updates between sites, core lab, and imaging specialists on echo educational needs for improving quality.
• Analyze data to create metric reports to communicate trial echo quality and any roadblocks to upper management.
• Provides resolutions for approval (e.g. new metrics and tools) for tracking follow ups throughout trial lifecycle.
• Provide final review Sci Comm literature/data of moderate complexity.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees