Senior Trial Operations Specialist

hace 1 semana


Buenos Aires, Buenos Aires C.F., Argentina IQVIA Argentina A tiempo completo

We are seeking an accomplished Sr. Trial Operations Specialist to oversee local trial management services in a country or countries. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials from start-up to closeout.

About the Role:
  • Oversight of assigned projects at the country level for end-to-end project management.
  • Ensure adherence to Sponsor SOPs, WIs, policies, GCP, local regulatory requirements.

This position involves serving as the primary company contact for assigned trials at the country level and monitoring local/country teams' progress against planned timelines and patient recruitment rates.

Responsibilities:

  1. Develop local trial procedures and tools, recruitment planning, contingency management, and budget forecasting.
  2. Maintain and update trial management systems, utilizing study tools and management reports to analyze trial progress.
  3. Prepare for and conduct HA inspections and internal Quality Assurance audits.
  4. Communicate study progress and issues to study management teams and business partners.
Requirements:
  • Bachelor's degree in a health or science-related field.
  • Minimum of 5 years of local trial management experience in the pharmaceutical industry or CRO with CR experience.
  • Working knowledge of ICH-GCP, company SOPs, local laws and regulations, assigned protocols, and protocol-specific procedures.
  • Strong IT skills in software and company systems.
  • Excellent communication and decision-making skills.


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