Senior Site Start-up Associate
Job Summary
To support biotech, medtech, and specialty pharma companies, the full-time Senior Site Start-up Associate will manage submission timelines, oversee essential document collection, and negotiate contracts while working remotely.
Key responsibilities
- Forecasts submission and approval timelines, providing contingency plans for delays
- Prepares ongoing submissions and amendments required by local regulatory authorities
- Negotiates site-specific contracts and budgets, ensuring compliance with local regulations
Required qualifications
- Undergraduate degree or equivalent in a clinical, science, or health-related field
- 5+ years of direct study start-up experience
- Thorough knowledge of FDA Guidance Documents, EU Directives, and local regulations
- Expertise in developing and reviewing Informed Consent Form templates
- Ability to build strong relationships across the organization
Complete Job Description
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