Affiliate Manager

• Initiate and coordinate clinical trial site activation activities and essential document management
• Compile high-quality Investigator Initiation Packages leading to site initiation approval
• Prepare, validate, and submit regulatory documents including IIP, IRB approval forms, and FDA 1572/Attestation Forms
• Coordinate supporting roles and activities to ensure timely site activation
• Support central and local ethics committee packages, submissions, approvals, and communications
• Support investigators with local IRB workflows from preparation through approval
• Prepare, handle, and distribute clinical documentation and reports
• Support and implement activities in the Shared Investigator Platform
• Coordinate essential documents and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and annual ethics approvals
• Maintain IRB/Ethics and other committee activities
• File documents to the Trial Master File and assist with periodic quality reviews
• Update and maintain clinical trial systems tracking site compliance and performance
• Support investigator sites and study teams with audit and inspection responses
• Maintain communication with study teams and investigator sites; provide country/site updates
• Disseminate ethics approvals and communicate site approvals to stakeholders
• Conduct site personnel awareness sessions as needed
• Identify and resolve investigator site issues and support corrective and preventive actions
• Act as a subject matter expert or point of contact for site activation, systems, processes, and global initiatives
• Support mentoring of new hires
• Complete required training, timesheets, expense reports, and CV updates
• Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements

Affiliate Manager jobs in Turkey

Site Activation Partner I – Temporary Contract