Senior Analyst, Clinical Trials and Site Contracts

Senior Analyst, Clinical Trials & Site Contracts

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 Senior Analyst, Clinical Trials & Site Contracts, you will be responsible for negotiating, initiating, executing, and managing complex clinical study contracts with third-party vendors to support clinical trial operations. In alignment with applicable regulations and Edwards Lifesciences policies, you will oversee the full contract lifecyclefrom initiation through completion or terminationensuring compliance and operational efficiency. This is a hybrid role (office and remote blend). 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 :

• Initiate, redline, and negotiate 3rd party complex contracts based on full knowledge of financial, regulatory and clinical requirements
• Negotiate trial budgets with clinical sites to ensure compliance with company-approved guidelines and alignment with fair market value utilizing approved budget templates
• Analyze need for contract amendments or renewals; evaluate prior terms and conditions, and make recommendations and / or negotiate changes within guidelines and regulations
• Collaborate with key stakeholders to receive and provide guidance on contracts terms and conditions. Identify risks and communicate to key stakeholders of the company
• Manage contracts administration through corporate-required platforms and department trackers, including status updates, repository maintenance, data input, report generation, and report analysis
• Create budget, contract and letter templates, as requested by management; suggest changes to contractual terms and conditions associated with contract and budget templates
• Provide training to incoming staff on simple and moderate contract matters and on EW policies and procedures
• In Collaboration with the Manager, initiate and maintain the Financial Score Card and Rate Cards for Sites
• Manage the contract life-management cycle with the Study Teams and other internal functions to identify and streamline processes for Site Activation from Site Selection
• Other duties and projects as apply

What you'll need (Required) : Bachelor's degree in a related field, combined with 5 years of professional experience in contract negotiation and administration, financial tracking and analysis aligned with contractual obligations, and data analyticsor equivalent experience as defined by Edwards criteria. Experience in healthcare related clinical contracts.

What else we look for (preferred) : J.D., or Contracts or Paralegal certification. Strong budget and contracts negotiation experience. Previous clinical research / clinical trial experience. Strong analytical and automation experience.

Additional skills : Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, Excel, and SharePoint. Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives with focus and with minimal impact to business. Excellent problem-solving, organizational, and critical thinking skills. 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. Advanced problem-solving skills. Strong knowledge of clinical research and operations acumen. Full knowledge of contract terms and conditions relating to clinical trials. Good leadership skills and ability to influence change. 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 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.

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 $80,000 to $110,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will 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.