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Location: |
Dublin West
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Qualifications: |
Degree |
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Experience: |
3-4 Years |
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Job Type: |
Permanent
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Salary: |
Not Disclosed |
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Consultant: |
Brian Christensen |
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Clinical Operations Specialist - Dublin
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Clinical Operations Specialist - Dublin
Responsibilities:
Support clinical operations activities to facilitate and support clinical development functions in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). Maintain key clinical operations databases; interact with and manage key vendors.
Clinical Operations
• Liaise with Clinical Project Managers to ensure consistent conduct of studies
• Set up and maintenance central repository for frequently asked questions for compound/indication
• Set up and maintain vendor database
• Set up and maintain internal safety database
• Set up and maintain document tracking database
• Liaise with vendor to secure and maintain adequate and appropriate insurance cover for department and individual trials
• Review SAEs received from Safety Management vendor and provide queries/feedback for event
• processing/management
• Maintain internal SAE tracking database and provide information as needed to clinical project managers
• Track submission of expedited events to relevant parties
• Undertake clinical operations sub-projects as delegated by Director of Clinical Operations to support overall clinical operations functions; drug vendor management;
• Assist with preparation and submission of annual safety updates
• Assist with preparation of data for project publications
• Liaise with QA to develop a system for monitoring and handling temperature excursions during shipment/storage, including development of documentation to record temperature excursions and a CAPA process.
• Associated Clinical Trial Administrator tasks
• Review Clinical Trial Applications in collaboration with CPMs to ensure consistency across all projects
Experience:
• 4 years experience in Clinical Development in BioPharma industry (Sponsor and/or CRO)
• Good working knowledge of ICH, GCP and good working knowledge of the clinical trials process
• Experience of SAE handling
• Experience of clinical trial management
Please contact Brian Christensen on 01 685 4747 or forward your CV to applications@lifescience.ie
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