CTM or Sr. CTM , FSP- Mexico
Thermo Fisher Scientific
Lead clinical study teams at the country level to deliver study components on time, within budget, and in compliance with international guidelines and local regulations. Oversee site identification, qualification, monitoring, and closure while ensuring data quality and regulatory submissions.
Responsibilities
- Lead and manage local study team performance, including CRAs and CSAs
- Conduct site selection, qualification visits, and ongoing monitoring activities
- Prepare and maintain study budgets, agreements, and essential trial documents
- Coordinate regulatory submissions to ethics committees and authorities
- Identify and mitigate study risks while reporting progress to global teams
Requirements
- Experience leading clinical research teams in a therapeutic area
- Knowledge of ICH-GCP guidelines and regulatory requirements
- Proficiency with clinical trial management systems and documentation
- Site management and monitoring experience in clinical studies
- Strong project management and budget oversight skills
- Fluency in Spanish and English for Mexico-based role
Vacante publicada el 12 horas atrás
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