Assistant Trial Capabilities

Eli LillyCork

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.


Company Overview

About us

At Lilly, we make 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. Today more than 500 are based at our Global Business Solutions centre in Little Island, Cork. There we boast a vibrant workforce made up of over 35 nationalities, speaking over 27 languages.

Established in 2010 to gain efficiencies in Finance GBS Cork quickly excelled in its financial mandate, allowing the Cork leadership to ask, how can we apply these processes to other areas of the business? And so the GBS we have today was born, still leading in finance, but also evolving and expanding into diverse Business Service functions.

Our benefits package includes healthcare, pension and life assurance benefits, subsidised canteen, wellbeing facilities, Gym, Educational Assistance, Subsidised Bus from city centre, car-pooling incentives, bike to work scheme, on-site parking and much more.

At the GBS, it’s not just about what we do today, but how we can continuously improve and innovate for present and future operations.

Above all, it’s about being part of an open, welcoming and inclusive culture, one that is further enhanced by the dedication of our committees - Culture Club, Diversity & Inclusion, Sports & Social, Corporate Social Responsibility, Health Safety & Environment and Food.

“ We are excited now to add another capability to the existing GBS team. The Clinical Trial Capabilities Team will focus on clinical research and, in particular, clinical study start-up activities across the EU and other regions, e.g. Middle East, Africa and Russia. The Clinical Trial Capabilities Centre will allow us to provide an unparalleled clinical trial experience for investigators and patients and ultimately achieve Lilly’s goal of speeding innovation and bringing our medicines to patients who need them.

Basic Qualifications

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

Additional Skills/Preferences

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.

Region

Europe; Middle East; Africa

Country

Ireland

City

Cork

Position Location

Local

Job Expires

03-Jul-2020

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