Senior Trial Coordinator
Há 3 dias
Our company offers local trial management services to ensure the successful execution of clinical trials worldwide. Our team provides operational oversight of assigned protocols from start-up through to database lock and closeout activities.
Key Responsibilities:- Ensure quality data and trial documents/records are delivered compliant with clinical trial protocols, SOPs, ICH-GCP, and regulatory requirements.
- Manage contract reviews, approval, and delivery in accordance with service provider contracts, change orders.
- Act as primary contact for assigned trials at the country level and ensure local teams track project progress against planned timelines and monitor patient recruitment rates.
- Drive study compliance by maintaining and updating trial management systems, analyzing trial progress using available tools and reports, and participating in Health Authority inspections and internal Quality Assurance audits.
- Contribute to site-level recruitment strategies and contingency planning to achieve clinical research targets.
- Bachelor's degree in a health or science-related field.
- Minimum 2 years of experience in local trial management in the pharmaceutical industry or CRO with previous experience as a Clinical Research Associate.
- Strong knowledge of ICH-GCP, SOPs, local laws and regulations, assigned protocols, and associated protocol-specific procedures.
- Excellent decision-making and financial management skills, proficiency in speaking and writing the country language and English, and good written and oral communication skills.
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Senior Clinical Trial Coordinator
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