Senior Trial Capabilities Specialist

Lilly

Indianapolis (IN)

On-site

USD 66,000 - 154,000

Full time

3 days ago
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Benefits offered by this job

401(k) plan
Medical, dental, vision benefits
Well-being programs

Job summary

Lilly is seeking a Trial Capabilities Senior Associate to support clinical development by ensuring investigator sites meet enrollment and regulatory requirements. The role covers regulatory submissions, budget/contract execution, and maintaining a complete Trial Master File for inspection readiness, with local geography variations as needed.

The position requires a bachelor’s degree in a scientific or health-related field and at least two years of clinical research experience.

Qualifications

  • Bachelor’s degree preferably in a scientific or health related field.
  • Two years clinical research experience or relevant experience preferred.
  • Candidates must be legally authorized to work in the United States full-time.

Responsibilities

  • Initiate investigator activities, including collection and submission of regulatory documents.
  • Customize and negotiate informed consent documents and budgets with investigators and internal teams.
  • Negotiate and obtain fully executed contracts and manage training/compliance tracking.
  • Maintain Trial Master File accuracy and readiness for inspections.
  • Coordinate investigator grant responsibilities and financial reconciliation for studies.

Skills

Regulatory documentation
Budget negotiation
Project management
Communication
Self-management
Organizational skills
Lean Six Sigma

Education

Bachelor's degree in scientific or health-related field

Job description

Lilly is seeking a Trial Capabilities Senior Associate to support clinical development by ensuring investigator sites meet enrollment and regulatory requirements. The role covers regulatory submissions, budget/contract execution, and maintaining a complete Trial Master File for inspection readiness, with local geography variations as needed.

The position requires a bachelor’s degree in a scientific or health-related field and at least two years of clinical research experience.

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