Job Summary
A company is looking for a Senior Study Start-Up Specialist.
Key Responsibilities
- Independently identify and resolve site-related issues impacting activation timelines
- Manage preparation and submission of regulatory documentation and ensure compliance with local and international requirements
- Collect and maintain regulatory and ethics approvals and ensure essential documents are submitted to the Trial Master File
Required Qualifications, Training, and Education
- Bachelor's Degree or equivalent combination of education, training, and experience
- Pharmaceutical or related industry experience, including regulatory and study start-up experience
- Excellent knowledge of GCP, regulations, and Standard Operating Procedures
- Ability to mentor and lead junior staff
- Demonstrated ability to work independently and collaboratively in a fast-paced environment
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