Clinical Trials Associate in Abbott Park, IL

MAIN PURPOSE

• Provide comprehensive strategic and operational support to ensure regulatory approval and compliance for clinical trials conducted worldwide ex USA & Canada                                                                
• Support Regulatory Affairs Area and Affiliate colleagues responsible for development compounds with strategic and operational advice for clinical trials.

MAIN RESPONSIBILITIES:

Clinical Trial Subject Matter Expert

• Provide advice on submission strategy (e.g. VHP vs. National), contribution to substantial & non-substantial decisions for amendments, safety reporting processes, distribution and supply issues, GCP & safety issues and country specific requirements.                                                                   
• Serve on CTA submission team meetings as area and affiliate strategy regulatory representative
• Provide ad hoc support for CTA related projects throughout the organization.

Operational Support                                                                     

• Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities; substantial amendments, end of trials notifications etc
• Preparation of cover letters, Annexes 1, 2 and 3, liaison with VHP-coordinator
• Liaise with key contacts in Regulatory Affairs, Clinical Study Management, Clinical Operations, Supply Chain and local affiliates to identify & resolve issues
• Input into CA & EC response to questions/requests for information
• Support inspection readiness activities when applicable

Project Management, Process Compliance and Communication

• Ensure approved company CTA processes are followed within agreed timelines
• Undertake all necessary training in order to achieve compliance with internal/external processes
• Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met
• Monitor key project milestones, communicate changes to assigned stakeholders and management as agreed in company procedures
• Participate in process improvement initiatives
• Support SOP reviews and updates as required                                

GENERAL RESPONSIBILITY:

• Key internal and external interfaces
• Area & Affiliate Regulatory Product Leads
• Global Regulatory Leads
• Global Clinical Study Management, Clinical Field Operations
• Global Chemistry, Manufacturing & Controls
• Global Distribution and Supply Management
• Clinical Research Organizations (CROs as appropriate)
• Quality Assurance
• Local affiliate offices

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