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Study Operations Manager II

3 months ago

Toronto, Ontario, Canada Parexel Full time
The Study Operations Manager II (SOM II) has responsibilities for study and regional or specific country level activities from study start-up through conduct and study close on one or more studies, providing 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, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverablesServes as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studiesOversees 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 applicableProvides country level input on start-up and recruitment milestonesCollaborates 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 mitigationQualifications:Bachelor's of Science or Bachelor's of Arts degree with a minimum 7 years of relevant operational clinical trial experience requiredMaster's of Science or Master's of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience requiredA scientific or technical degree is preferred
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