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Details

Clinical Trials Manager


Reference:AXQD-048788 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Clinical Trials Manager
Our client, a biotechnology organisation are currently recruiting for a Clinical Trails Manager to join their team. The Clinical Trial Manager will have oversight of all clinical trials for organisation. The ideal candidate will have experience working on Phase2b or Phase 3 clinical trials.

Responsibilities
• Responsible for full trial execution from protocol generation and input to clinical trial report and manuscript writing and publications
• Accountable for ongoing and effective collaboration with senior management and co-workers on clinical trial progress
• Vendor appraisal and selection which will include CRO and Labs
• Involved in budgets and proposals
• Responsible for oversight on the Orphan Drug Program
• Must be familiar with start-up and the intricacies and possible risks and solutions for this on global basis
• Oversight of the selected vendors ensuring they are hitting agreed timelines, metrics

Requirements
• Significant Clinical Operations experience with managerial experience in planning, executing, and reporting clinical studies in a pharmaceutical company or contract research organisation
• At least 5 years experience in a clinical role within a pharmaceutical company or senior role in a contract research organisation
• Experience in completing the life cycle of Phase2b or Phase3 clinical trials
• Experience with maintaining and updating or contributing to Clinical Department Quality System
• Understanding of pre and post –marketing pharmacoviligence requirements
• Knowledge of clinical trial services (e.g. eCRF, IxRS, PRO and central laboratories)
• Understanding of financial budgeting and forecasting
• Knowledge of IMP supply logistics and CMO activities
• Understanding of general GMP activities
• Excellent knowledge of Good Clinical Practice, clinical trial design, data management operations, general understanding of regulatory environment, and global clinical drug development process.
• Effective site management and organisational skills, with ability to establish and maintain effective working relationships with third party vendors, senior management and co-workers
• Willingness to travel internationally up to 40%



If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252