Study Operations Manager I/II - FSP

Overview

The Study Operations Manager II (SOM II) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.

Responsibilities

• Leads the local study team on one or more studies.
• Provides back up to or assumes the responsibilities of the GSM as needed.
• Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner 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 and/or oversee the CRO responsible for these activities as applicable.
• Liaises with SCP, Lead SCP, Site Activation Par...