Global Clinical Operations Leader

Há 4 dias

São Paulo, São Paulo, Brasil beBeeClinicalResearch Tempo inteiro US$90.000 - US$110.000
Clinical Research Project Lead

Our organization seeks an experienced Clinical Research Project Lead to oversee study planning, site activation deliverables, and ensure compliance with regulatory requirements in a standalone country or satellite location.

This is a pivotal role that demands strong leadership skills, project management expertise, and a deep understanding of clinical trial operations.

The successful candidate will be responsible for developing and executing country-specific strategies for clinical trials, collaborating with global teams and local stakeholders to drive project success.

Responsibilities:
  • Develops and implements comprehensive study plans, ensuring timely completion of deliverables and compliance with regulatory requirements.
  • Leads site start-up activities for assigned projects, driving efficient execution and quality control.
  • Collaborates with local Institutional Review Boards (IRBs) and Health Authorities to ensure site readiness and compliance.
  • Coordinates the preparation and submission of local documentation packages for regulatory approval.
  • Ensures accurate and quality documentation of clinical trial data in the Trial Master File (TMF), including inspection readiness.
Qualifications:
  • Minimum 5 years' experience in clinical research operations, preferably with project management skills.
  • Strong understanding of clinical drug development, emphasizing trial set-up, execution, and monitoring.
  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.

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