StudyStartupManager

PSI is a leading Contract Research Organization with 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. 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 a