Manager, Clinical Case Review

Edwards Lifesciences•Irvine, CA

About The Position

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: The Case Review Manager leads the patient screening analysis and evaluation of baseline medical history and clinical imaging reports (e.g EDC screening records including clinic notes, lab results, cardiology assessments, CT and/or echocardiogram reports) to confirm protocol compliance and provide patient screening and case review support to clinical trial sites for Clinical Research Trials within THV Clinical Affairs. Serve as a subject matter expert (SME) to ensure trial patient safety by assuring compliance with clinical protocols through screening of medical history for early feasibility and pivotal trials in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with EW procedures and ethical standards. Lead the analysis and evaluation of baseline medical history including case report forms and source documentation (e.g medical records including clinic notes, right heart hemodynamics, medication lists, lab results, and pulmonary function tests) to confirm protocol compliance. Serve as subject matter expert by providing direction and guidance to execute deliverables in collaboration with study stakeholders and cross-functional teams. Provide medical insight and guidance to screening and trial management teams to expedite resolution of site requests. Conduct reviews and document medical narratives based upon screening/baseline source information to facilitate case reviews by study Screening Committees in accordance with regulatory requirements, trial safety processes, and EW procedures. Provide guidance and review medical history narratives from team members to ensure protocol compliance in accordance with screening process work instructions. Design training programs related to best practices for screening potential trial participants according to protocols and provide education to participating study sites Provide direction to team members to improve processes within the department and delegate tasks to team members for department projects and ensure team deliverables are met within the required timeline. • Participate and contribute to the development of clinical protocols and case report forms

Requirements

Bachelor's Degree in Registered Nurse, 8 years previous related experience working in a clinical setting or equivalent work experience based on Edwards criteria Required
Master's Degree or equivalent in Physician Assistant, Nurse Practitioner (e.g., Mid-level Practitioner), with 6 years previous related clinical experience
Registered Professional Nurse, Nurse Practitioner, or Physician’s Assistant
Board certified RN, NP, or PA Required

Nice To Haves

Previous related experience working a clinical setting or equivalent work experience based on Edwards criteria Preferred and Experience working in the setting of a clinical trial or equivalent work experience based on Edwards criteria Preferred
Excellent problem-solving, organizational, analytical skills.
Strong foundation in treatment of cardiovascular disease.
Experience with an electronic data capturing system (e.g iMedidata), image transfer systems (e.g Bio Clinica) and CTMS (Clinical Trial Management System) preferred.
Working knowledge of the principals of clinical research including Good Clinical Practice (GCP).
Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies skills including consultative and relationship management skills.
Excellent problem-solving and critical thinking skills.
Moderate understanding of pre-clinical testing protocols, hospital environments and sterile techniques.
Moderate understanding of biostatistics including principals of trial design, study hypothesis, and importance of clinical trial endpoints.
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

Leads the patient screening analysis and evaluation of baseline medical history and clinical imaging reports
Serve as a subject matter expert (SME) to ensure trial patient safety by assuring compliance with clinical protocols through screening of medical history for early feasibility and pivotal trials in accordance with regulatory requirements
Lead the analysis and evaluation of baseline medical history including case report forms and source documentation
Serve as subject matter expert by providing direction and guidance to execute deliverables in collaboration with study stakeholders and cross-functional teams.
Provide medical insight and guidance to screening and trial management teams to expedite resolution of site requests.
Conduct reviews and document medical narratives based upon screening/baseline source information to facilitate case reviews by study Screening Committees in accordance with regulatory requirements, trial safety processes, and EW procedures.
Provide guidance and review medical history narratives from team members to ensure protocol compliance in accordance with screening process work instructions.
Design training programs related to best practices for screening potential trial participants according to protocols and provide education to participating study sites
Provide direction to team members to improve processes within the department and delegate tasks to team members for department projects and ensure team deliverables are met within the required timeline.
Participate and contribute to the development of clinical protocols and case report forms