Edwards Lifesciences Senior Analyst, Clinical Contracts, Transcatheter Heart Valve Unit in Irvine, California
Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease.
The Senior Analyst Clinical Contracts will be in compliance with applicable regulations and EW policies, initiate, execute, and administer contracts with third parties to support clinical trial operations; manage the lifecycle of contracts from initiation to completion or termination.
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 receive 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
Other incidental duties
Education and Experience:
- Bachelor's Degree in in related field, 5 years of previous related experience in contract negotiation/administration and financial tracking/analysis against contracts Required andOther: Experience in healthcare related contracts Requiredin Advanced degree in related field Experience in international contract administration preferred Preferred
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 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 documentsAdvanced 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 EHS rules and requirements 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.