Trial Capabilities Associate

Role Summary

Trial Capabilities Associate responsible for clinical trial site activation activities, including contract and budget negotiations with clinical trial sites across North America. The role establishes contractual agreements with sites and Investigators participating in Lilly-sponsored trials and drives acceleration in budget and contract activation while ensuring quality and compliance with global regulations and Lilly policies. The position collaborates across trials in a dynamic portfolio and is based in the Indianapolis area.

Responsibilities

• Initiate clinical trial site activation activities related to budget and contract negotiation and execution.
• Analyze clinical trial agreement and budget issues and communicate Lilly’s position to sites, applying a Negotiation Guidance Document and relaying the legal basis behind Lilly’s positions during negotiations.
• Negotiate Master Clinical Trial Agreements, Network Agreements, and multi-party Cooperative Agreements.
• Identify areas for process improvements with accountability for streamlining contract activities and driving innovation.
• Ensure timely updates to internal systems to ensure accuracy of site activation status.
• Anticipate potential issues with assigned sites and act proactively to ensure target activation timelines are met and exceeded.

Qualifications

• Required: Bachelor’s degree
• Required: 2 or more years' experience in clinical research or clinical development; experience specifically negotiating contracts and/or budgets in a clinical research or academic setting
• Required: Demonstrated organizational and time management skills
• Required: Demonstrated project management experience and skills
• Required: Must be local to the Indianapolis area
• Preferred: Experience in a compliance-driven environment
• Preferred: Proven demonstrable strength in negotiating clinical research agreements
• Preferred: Experience reviewing clinical trial budgets
• Preferred: Advanced degree in law or related field

Education

• Advanced degree in law or related field (Preferred)

Skills

• Contract and budget negotiation
• Clinical trial site activation
• Regulatory compliance knowledge
• Process improvement
• Project management
• Cross-functional collaboration