Edwards Lifesciences Forecasted Opportunity- Senior Analyst, Clinical Contracts in Irvine, California
This position has been posted in anticipation for future openings within Clinical Research. We anticipate hiring a Senior Analyst, Clinical Contracts. If you meet the minimum job requirements, you will receive additional information about our Clinical Affairs Talent Community. .
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 years experience of previous related experience in contract negotiation/administration and financial tracking/analysis against contracts Required and
Other: Experience in healthcare related contracts Required
in 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 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 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.