Senior Clinical Contracts Analyst - 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.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
As the Senior Clinical Contracts Analyst for our Surgical team, you will be responsible for the full contract lifecycle and ongoing management of HCP agreements; including partnering closely with internal stakeholders and (clinical study teams, legal, finance, compliance) third parties (clinical research organizations, consultants) to develop and manage the execution of a variety of HCP agreements while applying legal, contracting, and clinical expertise. This is a hybrid role (office and remote blend) with 2 days on-site each week. Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.
How you’ll make an impact:
+ Draft, negotiate, and execute the full contract lifecycle for a variety of complex HCP agreements while utilizing appropriate Edwards systems
+ Assess and analyze the need for HCP contract and budget amendments
+ Provide guidance and make recommendations to stakeholders while mitigating risk to Edwards
+ Conduct ongoing contract lifecycle management for HCP agreements
+ Onboard new HCPs across appropriate Edwards systems
+ Serve as project and/or subject matter expert (SME) for business unit and organizational initiatives
+ Identify and mitigate risks with moderate to high exposure to Edwards and create corrective action plan to mitigate and prevent risk
+ Escalate contract delays (external/internal issues and hurdles) in a timely manner to leadership and key stakeholders, and provide appropriate solutions
+ May track payment milestones against contract terms and resolve payment queries and confirm contract compliance
+ Manage contracts administration through corporate-required platforms and department trackers, including status updates, repository maintenance, data input, report generation, and report analysis
+ May be cross-trained to process grants and regional events through appropriate Edwards systems
What you’ll need (Required):
+ Bachelor's Degree in related field
+ Minimum 5 years of previous related in contract negotiation/administration, and financial tracking/analysis against contracts
What else we look for (Preferred):
+ Paralegal certificate
+ Experience in healthcare related HCP contracts
+ Experience working in a regulated industry
Additional skills:
+ Proven advance expertise in Microsoft Office Suite, including PowerPoint, Excel, and Word and ability to operate general office machinery
+ Excellent written and verbal communication skills
+ Strict attention to detail
+ Excellent problem-solving, organizational, and critical thinking skills
+ 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
+ Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
+ Full knowledge and understanding of Edwards policies, procedures and guidelines relevant to contract negotiation and administration
+ Full knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
+ Full understanding of regulatory requirements (e.g., CFR, GCP) and documents
+ Strong knowledge of clinical research and operations acumen
+ Full knowledge of contract terms and conditions relating to clinical trials
+ 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, the base pay range for this position is $78,000 to $110,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career 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.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
As the Senior Clinical Contracts Analyst for our Surgical team, you will be responsible for the full contract lifecycle and ongoing management of HCP agreements; including partnering closely with internal stakeholders and (clinical study teams, legal, finance, compliance) third parties (clinical research organizations, consultants) to develop and manage the execution of a variety of HCP agreements while applying legal, contracting, and clinical expertise. This is a hybrid role (office and remote blend) with 2 days on-site each week. Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.
How you’ll make an impact:
+ Draft, negotiate, and execute the full contract lifecycle for a variety of complex HCP agreements while utilizing appropriate Edwards systems
+ Assess and analyze the need for HCP contract and budget amendments
+ Provide guidance and make recommendations to stakeholders while mitigating risk to Edwards
+ Conduct ongoing contract lifecycle management for HCP agreements
+ Onboard new HCPs across appropriate Edwards systems
+ Serve as project and/or subject matter expert (SME) for business unit and organizational initiatives
+ Identify and mitigate risks with moderate to high exposure to Edwards and create corrective action plan to mitigate and prevent risk
+ Escalate contract delays (external/internal issues and hurdles) in a timely manner to leadership and key stakeholders, and provide appropriate solutions
+ May track payment milestones against contract terms and resolve payment queries and confirm contract compliance
+ Manage contracts administration through corporate-required platforms and department trackers, including status updates, repository maintenance, data input, report generation, and report analysis
+ May be cross-trained to process grants and regional events through appropriate Edwards systems
What you’ll need (Required):
+ Bachelor's Degree in related field
+ Minimum 5 years of previous related in contract negotiation/administration, and financial tracking/analysis against contracts
What else we look for (Preferred):
+ Paralegal certificate
+ Experience in healthcare related HCP contracts
+ Experience working in a regulated industry
Additional skills:
+ Proven advance expertise in Microsoft Office Suite, including PowerPoint, Excel, and Word and ability to operate general office machinery
+ Excellent written and verbal communication skills
+ Strict attention to detail
+ Excellent problem-solving, organizational, and critical thinking skills
+ 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
+ Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
+ Full knowledge and understanding of Edwards policies, procedures and guidelines relevant to contract negotiation and administration
+ Full knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
+ Full understanding of regulatory requirements (e.g., CFR, GCP) and documents
+ Strong knowledge of clinical research and operations acumen
+ Full knowledge of contract terms and conditions relating to clinical trials
+ 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, the base pay range for this position is $78,000 to $110,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career 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