Site Activation Leader

• Lead site activation planning and strategy development for assigned clinical studies
• Oversee site activation milestones and deliverables from site feasibility through last site activation
• Monitor and report site activation progress across multiple studies and mitigate delays or risks
• Lead cross-functional teams to resolve site activation challenges
• Develop, coordinate, and execute study critical path plans covering site feasibility, site selection, regulatory green light, site initiation, site activation, system setup, TMF/EDL management, EC and RA/MoH strategy, ICF customization, risk mitigations, and related tools, documents, and reporting
• Provide guidance to site activation team members
• Liaise between project management, site start-up teams, and site activation functions
• Lead internal communication on site activation status and actions
• Coordinate with clinical operations leadership to align activities with study objectives
• Manage client relationships and communication regarding timelines and deliverables
• Serve as Study Start-Up Subject Matter Expert for designated client accounts
• Support business development through site activation expertise in proposals and bid pursuit meetings
• Implement standardized site activation processes and best practices
• Analyze site activation metrics and drive process optimization
• Ensure compliance with regulatory requirements and company SOPs
• Contribute to site activation procedures and templates
• Champion quality initiatives
• Lead use of CTMS, EDC, IXRS, and TMF systems
• Oversee documentation of site activation processes and outcomes
• Optimize project planning systems for timelines and resource allocation
• Ensure data integrity and system maintenance
• Generate strategic reports and metrics for leadership review

• 4–7 years of experience in clinical research operations with site activation leadership
• Proven experience leading site activation teams and processes
• Comprehensive knowledge of clinical trial start-up processes and requirements
• Strong background in regulatory compliance in clinical research
• Extensive experience working with clinical research sites and investigators
• Demonstrated understanding of clinical trial timelines and milestone management
• Experience with process improvement and team leadership
• Bachelor's degree in Life Sciences, Healthcare, Business Administration, or related field
• Excellent proficiency with CTMS, EDC, IXRS, and TMF systems
• Strong project planning and management software knowledge
• Comprehensive knowledge of clinical trial regulations and Good Clinical Practice
• Deep understanding of site activation processes and requirements
• Extensive familiarity with clinical research operations and workflows
• Advanced project management and strategic planning abilities
• Excellent written and verbal communication skills with senior stakeholders
• Strong management capabilities
• Excellent problem-solving and critical thinking skills
• Attention to detail and accuracy in complex documentation
• Excellent time management and ability to prioritize multiple complex projects
• Cross-functional leadership and coordination
• Change management and process improvement expertise
• Client relationship management and business development support