Clinical Research Director (P4-P5)

Eli Lilly and CompanyUs, IN
Onsite

About The Position

Eli Eli Lilly and Company seeks a Clinical Research Director (P4-P5) to identify and deliver strategic initiatives in support of global clinical trials. Develop and optimize sponsor oversight documents, processes, and activities. Lead business integration, planning, and implementation efforts. Identify areas for process improvements and efficiency gains. Oversee vendor performance, productivity, and accountability. Evaluate consolidated quality elements, identify trends, and initiate actions to mitigate risk. Ensure inspection readiness related to vendor partnerships.

Requirements

  • Bachelor’s degree in Pharmacy or a closely related scientific field.
  • 5 years of progressively responsible experience with Phase 2 and Phase 3 Global trials for global Clinical Research.
  • 3 years of experience with managing global clinical research organizations or external vendor oversight for the execution of clinical trials.
  • 3 years of experience with quality management to ensure inspection readiness.
  • 3 years of experience with trial risk management.
  • 3 years of experience with clinical trial/site data analytics to ensure improved quality of clinical trial data.
  • Experience in utilizing Excel and Power BI for analysis and reporting.
  • Experience with electronic data capture tools for patient reported outcomes.
  • Technical experience with and application of GCP ICH requirements for application across a global environment.

Responsibilities

  • Identify and deliver strategic initiatives in support of global clinical trials.
  • Develop and optimize sponsor oversight documents, processes, and activities.
  • Lead business integration, planning, and implementation efforts.
  • Identify areas for process improvements and efficiency gains.
  • Oversee vendor performance, productivity, and accountability.
  • Evaluate consolidated quality elements, identify trends, and initiate actions to mitigate risk.
  • Ensure inspection readiness related to vendor partnerships.

Benefits

  • company bonus
  • company-sponsored 401(k)
  • pension
  • vacation benefits
  • medical benefits
  • dental benefits
  • vision benefits
  • prescription drug benefits
  • flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
  • life insurance
  • death benefits
  • certain time off and leave of absence benefits
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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