Senior Study Startup Specialist

Job Summary

A company is looking for a Contract Senior Study Startup Specialist (SSUS).

Key Responsibilities

• Oversee and lead all study start-up activities in compliance with regulatory requirements
• Prepare and obtain approvals for Informed Consent Forms and manage ongoing submissions to ethics committees and regulatory authorities
• Collaborate with Clinical Trial Managers to track site activations and manage study budgets and contracts

Required Qualifications

• University Degree or equivalent, preferably in a medical/science-related field with 8+ years of related experience
• Demonstrated knowledge and understanding of clinical trials and project management
• Familiarity with International Council for Harmonization (ICH) guidelines