Our client makes a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals, circa 500 of whom are based at our Global Business Solutions centre in Little Island, Cork. There we boast vibrant workforce made up of over 35 nationalities, speaking over 27 languages.

Job description

The Clinical Trial Capabilities Assistant role provides technical support to the clinical trial capabilities team in support of clinical development. The assistant is responsible for activities related to investigator sites readiness, maintenance and close out. The assistant will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

Key Objectives / Deliverables:

Clinical Trial Responsibilities

• Initiate investigator site activities, including collection and submission of regulatory documents.
• Track and ensure site compliance to effectively drive timelines aligned with company priorities
• Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
• Support TPO and investigator payments as appropriate
• Manage site account requests
• Invoice query resolutions
• Identify, communicate, and resolve issues
• Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.
• Ensure appropriate archiving of documents to meet Lilly record retention polices and regulatory requirements.

Qualification Requirements:

• Applied knowledge of project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Ability to learn and comply with regulatory requirements and internal policies.
• Effective communication, team work and problem solving skills
• Very good attention to details and accuracy
• Self-management and organizational skills
• Excellent computer skills

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status