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Details

Senior Clinical Trials Operations Manager


Reference:ARYJ-370280 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Senior Clinical Trials Operations Manager
Our client a global biopharmaceutical organisation is currently recruiting for a Senior Clinical Trials Operations Manager to join their team on a permanent basis. As Senior Clinical Operations Manager you will be responsible for managing the day-to-day operational activities that support the sponsored clinical trials.

Responsibilities
• Facilitate and accelerate the designing, planning, developing and monitoring of clinical trial(s) according to FDA and ICH guidelines that meet or exceed the CDP.
• Forecast and manage study-related finances within established budget parameters and communicate project status to clinical team
• Manage and track study-related activities, including: set up and management of Trial Master File (TMF) and/or electronic TMF (eTMF), investigational product/laboratory kit shipments, site-monitoring visit reports review/approval, vendor agreement review/ approval and study-specific plan/guideline development
• Manage Contract Research Organization (CRO)/ independent contractors and facilitate communication
• Assist in the selection of trial sites and investigators and with the negotiation/execution of site budgets and clinical trial agreements (CTAs)
• Track vendor contracts/payments
• Identify and mitigate study-related issues in a timely and efficient manner
• Tracks timely resolution of deficiencies identified in audit report
• Perform periodic review of TMF/eTMF to ensure accuracy and completeness. Assist with archive TMF/eTMF following study closeout
• Plan, coordinate and prepare for internal/external presentations, visual aids, slides, posters, and attend external meetings for projects

Requirements
• Science degree in related field, scientific background
• 7+ years’ experience in pharmaceutical clinical research including organizing and coordinating clinical trials
• Thorough knowledge of Food and Drug Administration (FDA) ICH/GCP and European regulations
• Strong analytical skills
• Excellent written and verbal communication skills
• Ability to quickly adapt to new technologies
• Ability to travel, including overnight travel, for business-related activities

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

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