Clinical Contracts Analyst, Trials and Sites - Edwards Lifesciences
Irvine, CA
About the Job
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
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.
As the Clinical Contracts Analyst , you will negotiate and develop contracts and budgets associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts. The position will be on-site at our Irvine headquarters 5 days/week.
How you will make an impact:
+ Specific to clinical trial sites, prepare initial contract(s) and draft(s); redline and negotiate contracts, utilizing Legal Department templates; demonstrate clinical knowledge and adhere to regulatory requirements; assist in proposing new language for templates.
+ Negotiate site-specific clinical trial budgets for per-patient procedures and trial-related costs based on basic financial knowledge and in adherence with regulatory requirements.
+ Identify risks and analyze potential impact to company; communicate risk to key stakeholders.
+ Communicate and collaborate with key internal stakeholders, including THV Project Managers, Legal, Compliance and Finance to obtain or clarify data required for budgets and contracts; share contracting strategies and discuss potential risks to trial timelines and deliverables.
+ Collaborate with external stakeholders (hospital and/or university research office, finance office, and external or internal counsel) to negotiate budgets and contracts and to collect required documentation for executed contracts.
+ Submit proposed final draft and supporting documentation through Legal Department’s electronic contracts management system for contract approval and secure appropriate signatures within specified signing authority; utilize company systems to store executed contracts and manage on-going assignments.
What you will need (required) :
+ Bachelor's Degree in related field
+ Minimum 3 years of previous related experience in contract preparation, negotiation, redlining, and budget negotiations
+ Experience in healthcare related contracts
What else we look for (preferred) :
+ Previous clinical research/clinical trial experience
+ Strong budget negotiation experience
+ Contract or paralegal certification
Additional Skills:
+ Proven expertise in Microsoft Office Suite, including PowerPoint, Excel, and Word and ability to operate general office machinery
+ Good written and verbal communication skills and interpersonal relationship skills
+ Demonstrated problem-solving and critical thinking skills
+ Moderate knowledge and understanding of Edwards policies, procedures and guidelines relevant to contract negotiation and administration
+ Moderate knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
+ Moderate understanding of regulatory requirements (e.g., CFR, GCP) and documents
+ Advanced proficiency in Microsoft Office Suite, including Excel, and Word
+ Ability to manage confidential information with discretion
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast paced environment
+ Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific project
+ Ability to build productive internal/external working relationships
For California, the base pay range for this position is $65,000 to $92,000 (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.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
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.
As the Clinical Contracts Analyst , you will negotiate and develop contracts and budgets associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts. The position will be on-site at our Irvine headquarters 5 days/week.
How you will make an impact:
+ Specific to clinical trial sites, prepare initial contract(s) and draft(s); redline and negotiate contracts, utilizing Legal Department templates; demonstrate clinical knowledge and adhere to regulatory requirements; assist in proposing new language for templates.
+ Negotiate site-specific clinical trial budgets for per-patient procedures and trial-related costs based on basic financial knowledge and in adherence with regulatory requirements.
+ Identify risks and analyze potential impact to company; communicate risk to key stakeholders.
+ Communicate and collaborate with key internal stakeholders, including THV Project Managers, Legal, Compliance and Finance to obtain or clarify data required for budgets and contracts; share contracting strategies and discuss potential risks to trial timelines and deliverables.
+ Collaborate with external stakeholders (hospital and/or university research office, finance office, and external or internal counsel) to negotiate budgets and contracts and to collect required documentation for executed contracts.
+ Submit proposed final draft and supporting documentation through Legal Department’s electronic contracts management system for contract approval and secure appropriate signatures within specified signing authority; utilize company systems to store executed contracts and manage on-going assignments.
What you will need (required) :
+ Bachelor's Degree in related field
+ Minimum 3 years of previous related experience in contract preparation, negotiation, redlining, and budget negotiations
+ Experience in healthcare related contracts
What else we look for (preferred) :
+ Previous clinical research/clinical trial experience
+ Strong budget negotiation experience
+ Contract or paralegal certification
Additional Skills:
+ Proven expertise in Microsoft Office Suite, including PowerPoint, Excel, and Word and ability to operate general office machinery
+ Good written and verbal communication skills and interpersonal relationship skills
+ Demonstrated problem-solving and critical thinking skills
+ Moderate knowledge and understanding of Edwards policies, procedures and guidelines relevant to contract negotiation and administration
+ Moderate knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
+ Moderate understanding of regulatory requirements (e.g., CFR, GCP) and documents
+ Advanced proficiency in Microsoft Office Suite, including Excel, and Word
+ Ability to manage confidential information with discretion
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast paced environment
+ Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific project
+ Ability to build productive internal/external working relationships
For California, the base pay range for this position is $65,000 to $92,000 (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.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
Source : Edwards Lifesciences