Senior Analyst, Clinical Patient Screening Core Labs
Edwards Lifesciences, Irvine, CA, United States
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)
Bachelor’s 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
Desired Skills and Attributes
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
Company Policies and Compliance
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).
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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)
Bachelor’s 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
Desired Skills and Attributes
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
Company Policies and Compliance
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).
#J-18808-Ljbffr