Global Clinical Research Operations Lead

hace 2 semanas


Providencia, Metropolitana, Chile Merck A tiempo completo
Job Description

This role requires a seasoned professional with experience in clinical research operations. The ideal candidate will have a strong background in site management, monitoring, and compliance. The following responsibilities are key aspects of this position:

  • SITE RELATIONSHIPS: Develop and maintain strong relationships with investigators and site staff to ensure seamless conduct of clinical studies.
  • CLINICAL STUDY SITE MANAGEMENT: Oversee the management of clinical study sites, ensuring compliance with ICH/GCP, sponsor SOPs, local laws and regulations, protocol, site monitoring plan, and associated documents.
  • STUDY PROTOCOL KNOWLEDGE: Develop in-depth knowledge of study protocols and related procedures to effectively manage and monitor clinical studies.
  • TASK COORDINATION: Coordinate and manage various tasks in collaboration with other sponsor roles to achieve study milestones.
  • SITE SELECTION AND VALIDATION: Participate in site selection and validation activities to identify suitable sites for clinical studies.
  • MONITORING AND OVERSIGHT: Conduct regular monitoring and oversight activities to ensure data integrity, subject safety, and compliance with regulatory requirements.
  • VISIT PLANNING AND EXECUTION: Plan and execute site visits, including validation, initiation, monitoring, and close-out visits, to ensure timely completion of studies.
  • REGULATORY DOCUMENTATION: Manage and maintain regulatory documentation, including study-related paperwork and records.
  • COMMUNICATION: Effectively communicate with investigators, site staff, and other stakeholders to address study-related issues and concerns.
  • PROBLEM RESOLUTION: Identify and resolve study-related problems and escalate them to senior management as needed.


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