Site Activation Manager

• Lead and manage customer-focused Site Start-Up deliverables within assigned projects at country, regional, or global level
• Direct technical and operational aspects of Site Start-Up deliverables
• Deliver activation-ready study sites on time, on budget, and in compliance with applicable regulations
• Oversee Site Start-Up activities from site selection and recommendation through site activation readiness and study life-cycle maintenance
• Develop Site Start-Up timelines and report progress, risks, and gaps to the project team, Project Manager, SSU Management, and Project Sponsor
• Collaborate with Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing
• Identify and evaluate Site Start-Up and regulatory pathway issues and implement solutions
• Ensure project deliverables meet internal and customer expectations, including projections, reports, updates, risk identification, mitigation, and management
• Develop and maintain customer relationships
• Oversee site identification and selection, regulatory activities, clinical trial agreements, investigator budgets, essential document collection, and SSU timelines
• Develop and manage integrated Site Start-Up timelines and report weekly progress
• Present SSU strategy and status at client meetings and communicate outcomes to project teams
• Review SSU budgets, monitor project profitability, and take corrective measures when necessary
• Manage scope, timelines, resources, budgets, and out-of-scope work
• Prepare core submission documents and clinical trial application dossiers for amendments
• Perform Regulatory Impact Assessments and oversee risk mitigation and review
• Assist with Subject Information Sheet/Informed Consent Form development
• Oversee collation, quality review, and submission of country-specific applications
• Contribute to SSU change initiatives
• Submit relevant documents to the Trial Master File according to company SOPs and sponsor requirements
• Perform other assigned work-related duties

• Bachelor’s Degree required; Higher Degree Preferred
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
• Good understanding of clinical protocols and associated study specifications
• Excellent understanding of clinical trial start-up processes
• Project management experience in a fast-paced environment
• Good vendor management skills
• Strong organizational skills with proven ability to handle multiple projects
• Excellent communication, presentation, and interpersonal skills
• Quality-driven in all managed activities
• Strong negotiating skills
• Strong problem-solving skills
• Ability to provide quality feedback and guidance to peers
• Equivalent experience, skills, and/or education will also be considered
• Minimal travel may be required (up to 25%)

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations, when appropriate