Manager

• Collaborate with major functional areas across clinical trial and business functions
• Identify and evaluate Site Start-Up issues, regulatory pathways, patient enrollment matters, and project risks
• Ensure project deliverables meet internal and customer expectations
• Develop and maintain customer relationships for assigned projects
• Provide oversight of project start-up deliverables throughout project life-cycle maintenance
• Manage regulatory maintenance activities, amendment submissions, authority and ethics committee communications, and import/export license extensions
• Oversee executed amended clinical trial agreements and investigator budgets with investigator sites
• Manage overall Site Start-Up timelines and realign plans as needed
• Develop integrated timelines and report weekly progress, including mitigation plans for timing risks and gaps
• Prepare and present Site Start-Up strategy and status at client meetings
• Review project budgets against milestones and profitability expectations; take corrective measures as needed
• Track out-of-scope work through backlog assignment
• Prepare core submission documents and clinical trial application dossiers for amendments
• Perform Regulatory Impact Assessments and oversee second-level reviews
• Assist with updates to master Subject Information Sheets and Informed Consent Forms
• Oversee collation, quality review, and submission of country-specific applications
• Contribute to Site Start-Up department change initiatives
• Submit relevant documents to the Trial Master File according to company SOPs and sponsor requirements
• Perform other assigned work-related duties

Explore Site Activation Manager at Syneos Health. Review requirements and application details.

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