Senior Analyst, Clinical Patient Screening Core Labs

Transcatheter Mitral and Tricuspid Therapies (TMTT) Business Unit

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

How you'll make an impact:

• 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.

What you'll need (Required):

• 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

What else we look for (Preferred):

• 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
• Full knowledge and understanding of policies, procedures, and guidelines relevant to clinical studies
• Full understanding of medical terminology as it relates to clinical studies
• 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

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. For California (CA), the base pay range for this position is $92,000 to $130,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.