Site Activation 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

• Equivalent experience, skills, and/or education will also be considered
• Ability to collaborate with Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing
• Knowledge of Site Start-Up and project regulatory pathways
• Ability to interpret complex issues and make sound business decisions
• Ability to manage project deliverables, projections, reports, updates, risks, timelines, and budgets
• Knowledge of life-cycle maintenance regulatory activities, including study maintenance and amendment submissions
• Experience overseeing clinical trial agreements, investigator budgets, competent authority and ethics committee communications, and import/export license extensions
• Ability to prepare core submission documents and clinical trial application dossiers for amendments
• Ability to perform Regulatory Impact Assessments
• Ability to develop or update Subject Information Sheets (SIS) and Informed Consent Forms (ICF)
• Ability to oversee country-specific application collation, quality review, and submission
• Ability to comply with Standard Operating Procedures, controlled document requirements, and Sponsor requirements
• Ability to use professionally recognized tools for planning and management of scope, timeline, resources, and budgets

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Minimal travel may be required (up to 25%)