
Start-Up Expert
Há 7 horas
Startup Specialist Role
This position involves collaborating with investigative sites to ensure a seamless start-up process and ongoing maintenance.
Key Responsibilities:- Maintain awareness of regulatory legislation and guidance in assigned countries.
- Coordinate data collection and submissions to authorities.
- Prepare and review study documentation and submissions.
- Liaise with vendors regarding regulatory submissions.
- Evaluate start-up and maintenance activities for compliance with laws, guidelines, and standards.
- Escalate issues timely and perform other duties as assigned.
- University/College degree in life sciences or related field.
- Experience in clinical research and knowledge of ICH guidelines and regulations.
- Fluent in English.
- At least 2 years in clinical development or regulatory start-up.
- Knowledge of ICH, RA, IRB/IEC regulations.
- General Office Environment.
- Seniority level: Entry level
- Employment type: Full-time
- Job function: Legal
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