Duties
• Responsible for managing execution of clinical trial agreements and related site-facing contracts to support clinical studies. Manages the negotiation, structuring, and administration of contractual documents that establish business relationships with vendors, customers and/or partners. This position will work closely with Clinical Operations, Finance, Legal, and CRO.
• Reviews and approves documents to protect the company's contractual position and ensure adherence to company policy. Advises management of contractual rights and obligations and provides interpretation of terms and conditions.
• Manages negotiation of clinical site agreements, including NDA’s, Clinical Trial Agreements, Power of Attorney agreements.
• Works closely with CRO partners to monitor contract status and performance
• Reviews clinical site budgets and assist in negotiation activitiestsik
• Contributes to development of contract templates, if applicable, and standard operating procedures
• Works with team members with active project management of ongoing contract issues; performs follow-up on all outstanding issues and suggest improvements as necessary
• Supports in generating amended contract and/or budget documents
Skills
• Must be able to demonstrate a knowledge of contract requirements, analysis of contract performance, and special provisions.
• Must be able to analyze and understand contract terms and conditions.
• Must be able to work with a high attention to detail.
• Must have excellent oral and written communications skills.
• Strong computer skills, including knowledge of databases and spreadsheets, are required.
• Must be able to demonstrate strong interpersonal and stakeholder service skills.
• Must be able to demonstrate time management, priority management, planning and coordination/multi tasking skills.
• Must demonstrate an ability to build relationships and work collaboratively.
• Project management skills are highly preferred.
• Must be able to maintain discretion and confidentiality.