Senior Site Activation Manager

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Lead and manage the initiation and activation of studies for designated projects.

• Foster cross-functional teamwork to achieve site activation goals and deliverables within the specified time frame and budget.

• Oversee and evaluate site activation metrics, recognize potential risks, and execute mitigation strategies.

• Collaborate with project teams on site qualification, selection, regulatory compliance, and gathering essential documents.

• Provide updates on project status, timelines, risks, and results to sponsors, project leadership, and internal stakeholders.

• Monitor and document site activation activities, budgets, and requirements for change management.

• Contribute to proposals, budgeting, bid defense efforts, and business development activities.

• Mentor and coach Site Activation Managers.

• Aid in the development of Standard Operating Procedures (SOPs), best practices, and ongoing process enhancements.

• Ensure adherence to ICH GCP, relevant regulations, SOPs, and study-specific requirements.

⛳️ Requirements

• A Bachelor's degree in a medical, biological, physical, health, pharmacy, or a related science field, or a two-year degree complemented by four years of clinical research experience.

• A minimum of seven years of experience in the CRO and/or pharmaceutical industry.

• Experience in Start-up Management, Project Management, and/or Site Management is preferred.

• Exceptional leadership, organizational, and project management capabilities.

• Comprehensive understanding of site activation processes, clinical project planning, execution, and regulatory requirements specific to countries or regions.

• Strong familiarity with ICH GCP guidelines, FDA/EU Clinical Trials Directives, and national regulatory standards.

• Ability to make independent decisions, address complex issues, and manage risks effectively.

• Skills in collaboration, communication, mentoring, and managing stakeholders across global and cross-cultural teams.

• Proficiency in both spoken and written English.

🏝️ Benefits

• Competitive benefits package based on location.

• An inclusive and equitable workplace.

• Opportunities for growth and professional development.

• A collaborative and inclusive environment.