Senior Study Specialist

Job Summary

A company is looking for a Remote Sr. Study Specialist in Global Study Operations.

Key Responsibilities

• Develop study-specific documentation and oversee site and investigator training materials
• Contribute to the oversight of site feasibility assessments, site selection, and manage essential documents in the Trial Master File
• Attend meetings as a representative of Global Study Operations and ensure accurate study entry and updates to ClinicalTrials.gov

Required Qualifications

• BA/BS or higher in nursing, life or health sciences preferred; relevant industry experience may be considered
• Experience in a biotechnology or pharmaceutical company
• Familiarity with oversight of external vendors, including SOW, budgets, and invoice management
• Proficient knowledge in study management and execution
• Understanding of compliance, quality, and drug development processes