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The Study Operations Manager (SOM) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on studies of limited complexity (a small number of countries/sites) or manages portions of a larger study (such as recruitment and retention).
Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
Oversees the preferred Contract Research Organization (CRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the CRO responsible for these activities as applicable
Provides country level input on startup and recruitment milestones
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. Accountable for resolution of site activation escalations to study teams including offering options for mitigation
Qualifications
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
A scientific or technical degree is preferred
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Pharmaceutical Manufacturing
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