Dutch Clinical Trial Capabilities Assistant

A Dutch speaking Clinical Trial Capabilities Assistant is required to join a leading global pharmaceutical business based in Cork. This is an opportunity to join a vibrant multi-cultural and multi-lingual team where you will play your part in making a difference for people the world over by supporting the business as it discovers, develops, and delivers medicines that help people live longer, healthier and more active lives. 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.


The Role:

• • 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 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

The Person:

• • Native Dutch speaker and fluency in English is essential for the role.
  • Bachelors’ Degree
  • 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

For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to [email protected]