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
• Resolve and escalate site issues and coordinate supporting roles to ensure timely site activation
• Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms
• Support central and local ethics committee packages, submissions, communications, and approvals
• Prepare, handle, and distribute clinical documentation and reports according to scope and SOPs
• Support Shared Investigator Platform activities aligned with Pfizer strategy
• Manage essential documents and updates throughout the study lifecycle, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals
• Maintain IRB/Ethics Committee activities and file documents to the Trial Master File
• Conduct periodic quality reviews of study files for accuracy and completeness
• Maintain clinical trial systems tracking site compliance and performance
• Support investigator sites and study teams with site audits and responses
• Maintain communication with study teams and investigator sites and provide country- and site-level updates
• Establish tools and disseminate ethics and site approval updates to stakeholders
• Conduct awareness sessions on client requirements and ongoing documentation compliance
• Identify and resolve investigator site issues and align on corrective and preventative actions
• Act as a Site Activation Partner point of contact or subject matter expert on systems, processes, projects, 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 South Korea

Site Activation Partner – FSP, Contractor