Trial Capabilities Associate

Eli Lilly and CompanyIndianapolis, IN
23h

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. The Trial Capabilities organization defines the strategy and is accountable for clinical trial site activation globally. We are driven to continually accelerate the delivery of medicines to improve patient outcomes and lives while exceeding our partner trial site expectations. Position Description: The Trial Capabilities Associate is responsible for performing clinical trial site activation activities. In particular, this position will conduct contract and budget negotiations directly with our clinical trial sites across North America. This position will be accountable for successfully establishing contractual agreements with sites and Investigators participating in Lilly sponsored clinical trials. This position will be expected to drive acceleration in the budget and contract activation activities through collaboration and innovative solutions. This position will have direct impact in Lilly’s evolving and fast-paced clinical trial activities. The Associate will need to balance accelerated and aggressive timelines of clinical development with ensuring quality and compliance with global regulations and Lilly’s policies.

Requirements

  • 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
  • Demonstrated organizational and time management skills
  • Demonstrated project management experience and skills
  • Must be local to the Indianapolis area
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Nice To Haves

  • Experience in a compliance-driven environment
  • Proven demonstrable strength in negotiating clinical research agreements
  • Experience reviewing clinical trial budgets
  • Advanced degree in law or related field

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 in a frontline capacity to sites. This will involve applying a prescribed Negotiation Guidance Document and relaying the legal basis behind Lilly’s positions while negotiating.
  • 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.

Benefits

  • Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
  • In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
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