Trial Operations Specialist

7 hours ago

Cork, Cork, Ireland beBeeProject Full time

Lilly is a global healthcare leader with a presence in over 180 countries. Our employees work together to discover and develop life-changing medicines that improve the lives of people around the world.

As a Trial Capabilities Associate, you will be responsible for ensuring the complete trial package required for regulatory submissions includes all necessary documents and tracks delivery timelines. You will partner with cross-functional teams, including Design Hub, Clinical Development, and Third Party Organizations, to define and deliver document requirements within agreed-upon timelines.

Key responsibilities include:

  • Providing guidance to the study team on Lilly required and regulatory documentation
  • Creating, updating, and tracking document requirements and delivery in the regulatory document tracker at the trial level
  • Communicating timelines with study team members and implementing risk mitigation strategies
  • Driving timely study priority and adopting accelerated novel approaches for high-priority trials

Required qualifications include a Bachelor's degree in a scientific or health-related field, applied knowledge of project management processes, and effective communication, negotiation, and problem-solving skills.

The ideal candidate will have two years of clinical research experience, excellent communication skills, and a strong understanding of data privacy regulations, intellectual property, and clinical trial regulations.

At Lilly, we are dedicated to helping individuals with disabilities actively engage in the workforce and promoting equal opportunities. We do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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