Clinical Trials Capabilities Associate

Collins Mcnicholas Recruitment

Cork

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. Requirements: 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 discussionandmore information on the role,please contactEloísa Ruiz. on 021 4911066or email eloisa.ruiz@collinsmcnicholas.ie. For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos! For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie.For more information on Collins McNicholas, contact one of our six branches across Ireland in Dublin, Cork, Galway, Sligo, Athlone, Limerick. This job originally appeared on RecruitIreland.com.

2045 days ago