Key Accountabilities:
Accountability
Supporting Activities
Site Activation Leadership and Strategy
- Lead site activation planning and strategy development for assigned clinical studies
- Oversee site activation milestones and deliverables to ensure timely and quality study start-up from site feasibility through last site activation
- Monitor and report on site activation progress across multiple studies and mitigate potential delays or risks
- Lead cross-functional teams to resolve complex site activation challenges and issues
- Develop, coordinate, and execute the study critical path plan. This includes but is not limited to Site Feasibility, Site Selection, Regulatory Green Light, Site Initiation, and Site Activation, as well as System Set-up, pertinent TMF/EDL Management, EC & RA/ MoH Strategy, ICF Customization, Risk Mitigations, Site Activation Requirements & Relevant Tools, Documents, and Reporting
Team Leadership and Stakeholder Management
- Provide guidance to site activation team members
- Serve as liaison between project management, site start-up teams, and site activation functions
- Lead regular communication with internal teams regarding site activation status and actions
- Coordinate with clinical operations leadership to align site activation activities with overall study objectives
- Manage client relationships and communication regarding site activation timelines and deliverables
Client Relationship Management and Business Development
- Serve as the Study Start-Up (SSU) Subject Matter Expert (SME) for designated client accounts, providing strategic guidance, best practice recommendations, and technical expertise to ensure optimal study initiation and site activation outcomes
- Support business development activities by providing site activation expertise in proposals and bid pursuit meetings (BPMs)
Process Development and Quality Leadership
- Implementation of standardized site activation processes and best practices across studies
- Analyze site activation metrics and drive process optimization initiatives