Associate, Clinical Study Start-up

Eli Lilly and Company

Indianapolis, Indiana, US
Base: $71,250 - $161,700; bonus/equity: compyny bo...
Clinical study start-up activities
Site regulatory document review
Irb/ec and regulatory submissions
Lead study start up activities for assigned projects, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals

Job Summary

  • Lead study start up activities for assigned projects, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals.
  • Support the Clinical Operations team in the successful execution of clinical trials from protocol concept to clinical trial report, aligning with international ICH/Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs).
  • Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Matching Summary

Lead study start up activities for assigned projects, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals.

Salary

Base: $71,250 - $161,700; Bonus/Equity: Company bonus; Benefits: Comprehensive benefit program

Skills & Requirements

Must-have

  • Clinical study start-up activities
  • Site regulatory document review
  • IRB/EC and regulatory submissions
  • ICH/Good Clinical Practice (GCP) guidelines
  • TMF document management
  • Study supply management

Nice-to-have

  • Cross-functional team collaboration
  • Proactive problem-solving
  • Effective communication skills
  • Influencing within a matrixed organization

Key Requirements

  • 5+ years clinical research experience
  • Bachelors degree in science-related field
  • Authorized to work in the US full-time

Work Rights

Authorized to work in the United States on a full-time basis

Tailored Resume

Cover Letter