• Responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies • Provides leadership, strategic planning, and organization skills to ensure the operational delivery of tasks • Serves as leader of the local study team on one or more studies • Provides back up to or assumes the responsibilities of the GSM as needed • Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level • Manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans) • Manages the study startup process in countries assigned or oversees the CRO responsible for these activities • Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethics Committees • Provides country level input on startup and recruitment milestones during planning • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.