The Study Operations Manager I (SOM I) has 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
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
May manage the study start up process in countries assigned
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required

3-5 years clinical trial study management experience required
Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
Demonstrated clinical research experience and/or study management/startup project manager experience
Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial operations experience required OR Master's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required

Country Study Operations Manager – Clinical Trial Manager

Key skills