Local Study Associate Director – FSP

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

📋 Description

• Oversees Local Study Team(s) at the country level to ensure the successful delivery of clinical study components.

• Guarantees the identification of sites, completion of site qualifications, setup, initiation, monitoring, closure, and archiving of documentation.

• Holds overall accountability for study commitments within the country and ensures timely delivery of data that meets quality standards.

• Directs and enhances the performance of the Local Study Team(s).

• Manages the site selection process by pinpointing potential sites and investigators.

• Evaluates monitoring visit reports as necessary and provides guidance to monitors on study-related issues.

• Actively identifies risks and facilitates the resolution of complex study challenges and concerns.

• Develops, maintains, and reviews risk management plans at the country study level.

⛳️ Requirements

• At least 3 years of experience in Development Operations (CRA, SrCRA) or related fields.

• Strong understanding of international guidelines such as ICH GCP and pertinent local regulations.

• Demonstrated capability to lead and inspire cross-functional teams to execute clinical trials on or ahead of schedule.

• Exceptional project management abilities.

• Outstanding team building and interpersonal skills.

• Excellent organizational capabilities.

• Superior verbal and written communication skills.

• Proficient in both written and spoken English language is required.

• Fluency in local language(s) is necessary.

🏝️ Benefits

• Flexible working arrangements.

• Opportunities for professional development.