Clinical Trial Manager

hace 6 horas


Xico, México Iqvia A tiempo completo
Job Summary

We are seeking a highly skilled Clinical Trial Manager to join our team at Iqvia. As a Clinical Trial Manager, you will be responsible for the regional and global coordination of clinical trial management activities for internally managed and outsourced trials.

Key Responsibilities
  • Lead the Study Management Team (SMT) and ensure regional and global clinical operations deliverables progress according to agreed-upon timelines and milestones.
  • Coordinate country and site feasibility, trial set-up, trial execution, and trial closure activities.
  • Develop and manage local trial-specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
  • Drive study compliance by maintaining and updating trial management systems, using study tools and management reports to analyze trial progress.
  • Participate in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
  • Escalate corrective and preventive actions (CAPA) to the Global Clinical Development Operations Trial Leader (GTL) and communicate study progress and issues to study management teams and business partners.
Requirements
  • Bachelor's or Master's degree in a health or science-related field.
  • 1-8 years of clinical trial management experience in the pharmaceutical industry or Contract Research Organization (CRO).
  • Superior clinical research operational knowledge and a proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
  • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol-specific procedures.
  • Strong IT skills in appropriate software and company systems.


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