Associate Manager, Clinical Strategy (Remote, US) Transcatheter Heart Valve (THV)

Edwards Lifesciences

Chicago Illinois

United States

Healthcare - Physician
(No Timezone Provided)

Edwards is the global leader in transcatheter heart valve replacement technologies designed for the non-surgical replacement of heart valves. Delivered via catheter while the heart is beating, these valves can enable patients to experience a better quality of life sooner than patients receiving traditional surgical therapies. Launched commercially in Europe in , and in the United States in , our transcatheter aortic heart valves are now available in more than 70 countries and are the most widely used transcatheter heart valves in the world. The Associate Manager, Clinical Strategy role will develop accurate and effective clinical protocols and associated study registration to align with strategic initiatives.Essential Job Functions & Responsibilities:Lead in the development of clinical protocols and associated documentation with accountability for successful completion within scope of project deliverables; manage the process to obtain, evaluate and incorporating input resolve from cross-functional reviewers input for document finalizationLead in the identification and evaluation of competitive research programs to understand clinical strategiesDetermine content (e.g., endpoints, eligibility) and timing of EW THV clinical trial postings in public databases, obtaining input from key stakeholdersResearch and evaluate literature and other data sources to compile applicable clinical inputs for the development of clinical study designs/synopsesOther incidental dutiesMinimum Education & Qualifications:Bachelor's Degree with 8 years of relevant clinical experience; OR Master’s Degree with 6 years of relevant clinical experience; OR PhD with 4 years of relevant clinical experienceExperience in clinical trial management, monitoring and/or site managementPreferred Qualifications:Experience writing clinical protocolsMedical Device industry experienceExperience in cardiology or interventional cardiology therapeutic areasKnowledge of FDA and EU MDR regulationsAdditional Talents & Expectations:General knowledge of statisticsProven successful clinical project management skillsProven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote)Advanced editing and proofreading skillsStrong problem-solving and critical thinking skillsExcellent written and verbal communication skills including negotiating and relationship management skillsAbility to read, write, and speak English fluentlyExtensive knowledge of relevant US and EU regulations and guidelines, Good Clinical Practice requirements and other applicable standardsExtensive knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)Ability to travel up to 10% of the time to scientific meetings/conferences and/or to our Irvine, CA corporate officeFor Colorado Residents Only: 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.The base pay range for this position is $, to $,.Additional information can be found through the link below:Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.

Associate Manager, Clinical Strategy (Remote, US) Transcatheter Heart Valve (THV)

Edwards Lifesciences

Chicago Illinois

United States

Healthcare - Physician

(No Timezone Provided)

Edwards is the global leader in transcatheter heart valve replacement technologies designed for the non-surgical replacement of heart valves. Delivered via catheter while the heart is beating, these valves can enable patients to experience a better quality of life sooner than patients receiving traditional surgical therapies. Launched commercially in Europe in , and in the United States in , our transcatheter aortic heart valves are now available in more than 70 countries and are the most widely used transcatheter heart valves in the world. The Associate Manager, Clinical Strategy role will develop accurate and effective clinical protocols and associated study registration to align with strategic initiatives.Essential Job Functions & Responsibilities:Lead in the development of clinical protocols and associated documentation with accountability for successful completion within scope of project deliverables; manage the process to obtain, evaluate and incorporating input resolve from cross-functional reviewers input for document finalizationLead in the identification and evaluation of competitive research programs to understand clinical strategiesDetermine content (e.g., endpoints, eligibility) and timing of EW THV clinical trial postings in public databases, obtaining input from key stakeholdersResearch and evaluate literature and other data sources to compile applicable clinical inputs for the development of clinical study designs/synopsesOther incidental dutiesMinimum Education & Qualifications:Bachelor's Degree with 8 years of relevant clinical experience; OR Master’s Degree with 6 years of relevant clinical experience; OR PhD with 4 years of relevant clinical experienceExperience in clinical trial management, monitoring and/or site managementPreferred Qualifications:Experience writing clinical protocolsMedical Device industry experienceExperience in cardiology or interventional cardiology therapeutic areasKnowledge of FDA and EU MDR regulationsAdditional Talents & Expectations:General knowledge of statisticsProven successful clinical project management skillsProven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote)Advanced editing and proofreading skillsStrong problem-solving and critical thinking skillsExcellent written and verbal communication skills including negotiating and relationship management skillsAbility to read, write, and speak English fluentlyExtensive knowledge of relevant US and EU regulations and guidelines, Good Clinical Practice requirements and other applicable standardsExtensive knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)Ability to travel up to 10% of the time to scientific meetings/conferences and/or to our Irvine, CA corporate officeFor Colorado Residents Only: 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.The base pay range for this position is $, to $,.Additional information can be found through the link below:Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.