Clinical Trial Manager II

hace 7 días


Xico, México Johnson & Johnson Sa De Cv A tiempo completo
Job Summary

The Clinical Trial Manager II is responsible for the local management of clinical trials in a country or countries. This role is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocols from start-up through to database lock and closeout activities.

Key Responsibilities
  • Collaborate with Functional Manager and Clinical Research Manager for country protocol feasibility and site feasibility assessment.
  • Implement local criteria for site selection and ensure consistent conduct of pre-trial assessment visits.
  • Contribute to study management documents at a country level and lead local trial team activities in compliance with SOPs and applicable regulations.
  • Develop local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
  • Ensure timely reporting of Adverse Events, Serious Adverse Events, and Product Quality Complaints.
  • Maintain and update trial management systems and analyze trial progress.
  • Monitor country progress and initiate corrective and preventive actions when the trial deviates from plans.
  • Submit requests for vendor services and support vendor selection.
  • Forecast and manage country/local trial budget to ensure accurate finance reporting and trial delivery within budget.
  • Attend/participate in Investigator Meetings as needed and conduct local trial team meetings.
  • Review and approve Monitoring Visit Reports and site and local vendor invoices.
Requirements

The ideal candidate will have experience in clinical trial management, excellent communication and project management skills, and the ability to work in a fast-paced environment.



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