Country Study Operations Manager

This is a fully remote position, open to applicants in Mexico.

📋 Description

• The Country Study Operations Manager I (cSOM I) is responsible for overseeing study and specific country-level activities from the initiation of the study through its execution and closure on studies that are of limited complexity (involving a small number of countries/sites) or managing sections of a larger study (such as recruitment and retention).

• Assists Global Study Managers (GSMs), other SOMs, and the broader study management team by leading specific components of the project, managing particular countries, executing tasks of moderate complexity, and devising solutions to challenges as necessary to support deliverables.

• Acts as the leader of the local study team (including core members, ad hoc members, and other essential stakeholders as required) for one or more studies.

• Manages the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at the country level in alignment with the overall project plan, while overseeing and maintaining accurate country-level plans (e.g., timelines, budget, risk, and quality plans).

⛳️ Requirements

• A Bachelor’s of Science or Bachelor’s of Arts degree with at least 5 years of relevant operational clinical trial experience is required.

• A Master’s of Science or Master’s of Business Administration degree with a minimum of 3 years of relevant operational clinical trial experience is required.

• In-depth knowledge of one’s own discipline coupled with a solid understanding of other disciplines to ensure that the study achieves its objectives and to serve as a resource for others.

• Proven experience in clinical research and/or study management/startup project management.

• Demonstrated expertise in managing country-level operational activities and/or vendors.

🏝️ Benefits

• Health insurance

• Flexible work arrangements