Clinical Research Engagement Lead and Study Start Up Lead - fixed term

Tasks

• Drive Strategic Site Engagement: Develop and execute country-level site engagement strategies across disease areas, aligning local priorities with global clinical operational goals.
• Build Strategic Site Partnerships: Deepen relationships with investigators and key operational stakeholders to co-create solutions and enhance overall site satisfaction.
• Serve as Primary Point of Contact: Act as the local Clinical Operations Primary Point of Contact (PPOC) and escalation point for cross-study challenges, driving rapid resolution.
• Provide Study & CRO Oversight: Collaborate closely with CRO partners to oversee site monitoring performance, risk-based monitoring plans, eTMF completeness, and inspection readiness.
• Champion Portfolio Execution: Plan and execute country study goals, providing global teams with country-level feedback while proactively managing risk mitigations.
• Lead Country Start-Up Strategy: Drive efficient country-level start-up operations to ensure timely site activation, ethics board, and health authority interactions.
• Manage Regulatory & ICF Workflows: Architect Informed Consent Form (ICF) management and oversee clinical trial submissions, amendments, and regulatory packages throughout the trial lifecycle.
• Direct Budgeting & Contracting: Develop Fair Market Value-based budget strategies, draft site budgets, and negotiate contracts and indemnity documentation.
• Oversee Payments & Site Compliance: Strategically oversee payment processes, manage local vendor coordination, and ensure adherence to country-specific regulations.
• Drive Innovation & Automation: Identify opportunities for process standardization, workflow automation, and regional cross-functional alignment to accelerate trial start-up timelines.