Senior Releasing Analyst driving critical part supply solutions for Ford. Managing interfaces between supply base and logistics systems while supervising demand analysts and logistics providers.
About the role
- 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
- Previous clinical research/clinical trial experience (preferred)
- Contract/paralegal certification (preferred)
- Proven expertise in Microsoft Office Suite including Word, PowerPoint, Excel, and SharePoint
- Moderate knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
- Understanding of regulatory requirements (e.g., CFR, GCP)
- Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects
- Ability to build stable internal/external working relationships
- Ability to interact professionally with all organizational levels
- Strict attention to detail.
Benefits
- COVID Vaccination Requirement
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