PSI CRO
SCOPE OF RESPONSIBILITIES
1. Core responsibilities (the scope of responsibilities may vary and is dependent on project allocations and study startup process specifics in the country/region)
1.1. The Study Startup Manager leads study startup in 1 to 3 assigned countries on projects within a region starting from project start until site activation.
1.2. Ensures that startup deliverables in assigned countries are met.
1.3. Participates in development and update of project/country startup and site activation timelines.
1.4. Acts as a primary or secondary contact for client and vendors for startup matters within assigned countries. 1.5. Reviews the quality metrics and reports quality issues.
1.6. Ensures startup team compliance with project-specific training matrix and trains project team on Study Startup processes.
2. Resource Management & Training
2.1. Assists with Study Startup resource allocation in the assigned country(-ies).
2.2. Develops training materials, delivers training and provides methodological support to operational staff in within the assigned country(-ies).
2.3. Mentors and coaches assigned department staff in the country.
2.4. Takes up line management responsibilities for local Study Startup team members within assigned country(-ies).
3. Quality Assurance and Process Improvement
3.1. Identifies and escalates country-specific startup operational issues regional leads.
3.2. In cooperation with the Line Manager, monitors startup key performance indicators for projects in startup on a country level and implements improvement plans.
3.3. Develops and updates manuals, local instructions, and user guides relevant to Study Startup activities within the assigned country and provides local expertise and best practices to other PSI functions and clients.