Study Operations Manager II- FSP
When our values align, there's no limit to what we can achieve.
Must have Vaccine Experience- Unblinded experience a plus Remote- Canada 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 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 start-up 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 7 years of relevant operational clinical trial experience required
- Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required
- A scientific or technical degree is preferred
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