It’s an amazing opportunity for being part of a successful team in one of the most important Biopharma Companies in Ireland.
As part of the Clinical Trial Capabilities Team you will:
- Ensure that the Investigator sites meet the requirements to enrolling study participants into clinical trials.
- Collecting and submitting regulatory documents
- Being the point of contact for a site’s ERB and Competent Authority when applicable
- Communicate and negotiate budgets with site personnel and internal teams.
- Negotiate and obtain a fully-executed contract.
- Ensure site compliance to required training.
- Drive timelines aligned with Company priorities.
- Support ongoing activities during site maintenance and closeout.
- Communicate directly with sites to enable start-up and maintain an active collaboration with sites.
- Identify, communicate and resolve issues
- Ensure Country-specific regulatory and data privacy requirements are incorporated and all documents/systems.
- Populate internal systems to ensure the accuracy of trial/site performance.
- Obtain clinical trial authorizations and ethical approvals.
- Ensure Inspection readiness through an accurate and available Trial Master File.
- Provide feedback and shared learning for continuous improvement.
- Understand and comply with procurements, legal and financial requirements and procedures.
- Anticipate and monitoring dynamically changing priorities.
- Bachelor’s degree
- 2 year’s clinical research experience or relevant experience
- Understanding of the overall clinical development paradigm and the importance of efficient site initiation.
- Applied knowledge of project management processes and sills
- Appreciation of / experience in compliance-driven environment
- Ability to learn and comply with financial and legal guidelines and policies.
- Fluent in English and
- Italian or,
- French or,
- German, Spanish, Italian, Polish, Swedish, Danish, Finnish, Czech, Hungarian, Romanian, Dutch, Flemish, Swiss German, Austrian German, Slovakian, Arabic, Hebrew, Russian, Ukrainian, and Turkish
For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email email@example.com