Senior Analyst, Clinical Trials and Site Contracts

Edwards Lifesciences Corp•Irvine, CA

45d•$80,000 - $110,000•Hybrid

About The Position

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 lifecycle-from initiation through completion or termination-ensuring 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.

Requirements

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 analytics - or equivalent experience as defined by Edwards criteria
Experience in healthcare related clinical contracts
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

Nice To Haves

J.D., or Contracts or Paralegal certification
Strong budget and contracts negotiation experience
Previous clinical research/clinical trial experience
Strong analytical and automation experience

Responsibilities

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

Benefits

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.
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.

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