Clinical Contracts Analyst negotiating and developing clinical trial contracts ensuring compliance with regulations. Part of Edwards Lifesciences team transforming patient care with clinical evidence.
Responsibilities
Negotiate and develop contracts associated with clinical trials
Ensure contracts comply with regulations and manage the lifecycle of contracts
Initiate, draft, redline, and negotiate 3rd party moderately complex clinical related contracts based on substantial knowledge of financial/fair market value, regulatory and clinical requirements while demonstrating clinical knowledge
Recommend new/or revised language for contract templates
Identify risks (e.g. site incentives, legal issues, conflict of interest) and actively engage with management to provide recommendations for mitigation
Provide clinical input on functional contract terms, budgets, and scope of services to secure appropriate approvals in collaboration with key stakeholders
Analyze need for contract amendments or renewals and make recommendations, and/or negotiate changes, to terms and conditions
Identify risk associated with project timelines set by project teams, impacting team’s deliverables and timelines, and key stakeholders’ workload
Submit proposed final draft and supporting documentation through Legal Department’s RFA system for contract approval and secure appropriate signatures within specified signing authority
Identify opportunities for process improvement in collaboration with cross-functional teams; present and implement process improvement plans to management and/or key stakeholders.
Requirements
3 years experience of previous related work experience in contract negotiation/ administration and financial tracking/analysis against contracts
Experience in healthcare related clinical contracts
Bachelor's Degree in related field (preferred)
Strong experience drafting, reviewing, and negotiating clinical study contracts, including familiarity with terms and conditions, regulatory compliance, and stakeholder collaboration
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