Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project
Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level
Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)
Ensures compliance to relevant global and local, internal and external requirements, and regulations
Acts as the point of contact for all study level questions for the local study team

Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
Demonstrated clinical research experience and/or study management/startup project manager experience
Demonstrated experience in managing country level operational activities and/or vendors
Experience in study and quality management
Fluency in written and spoken English required

Country Study Operations Manager I

Key skills