Clinical Trials Manager

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeTrial Tempo inteiro R$500.000 - R$1.000.000

Local Trial Management Position Overview

This role is responsible for the local management of clinical trials or Medical Affairs data generation activities within a country or countries.

The position involves operational oversight of assigned protocols from start-up through to database lock and closeout activities.

Main Responsibilities:

  • Ensure high-quality trial data and documents are delivered in compliance with the assigned protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements.
  • Develop detailed budget proposals and manage contract compliance, including review and approval of external service provider contracts.
  • Maintain patient recruitment rates to meet target enrollment across allocated countries.
  • Drive study compliance by updating trial management systems and using available management reports to analyze trial progress.

Requirements:

  • Bachelor's degree in a health or science-related field.
  • Minimum 2 years of local trial management experience in the pharmaceutical industry or CRO, with previous experience as a Clinical Research Associate.
  • Strong knowledge of ICH-GCP, company SOPs, local laws and regulations, and associated protocol-specific procedures.
  • Proficient in speaking and writing the country language and English.

Language Skills:

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