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Senior Local Trial Coordinator
3 semanas atrás
Local Trial Manager
Job Description:
This role provides local management of clinical trials and medical affairs data generation activities in a country or countries.
Responsibilities:
- Ensure quality data and trial documents/records compliant with assigned clinical trial protocols, company SOPs, ICH-GCP, and regulatory requirements.
- Manage operational oversight of assigned protocol(s) at the country level from start-up through database lock and closeout activities.
- Develop high-level budget estimates and detailed proposals for Requests for Service, ensuring contract management including review and approval of ESP contracts and change orders.
- Act as primary contact for assigned trials at the country level, tracking project progress against planned timelines and monitoring patient recruitment to meet target enrollment across allocated countries.
- Drive study compliance by maintaining and updating trial management systems, using study tools and reports to analyze trial progress.
Requirements:
- Bachelor's degree in a health or science-related field.
- Minimum 2 years of local trial management experience in the pharmaceutical industry or CRO and previous experience as Clinical Research Associate.
- Strong working knowledge of ICH-GCP, SOPs, local laws and regulations, assigned protocols, and related procedures.
- Excellent decision-making and strong financial management skills.
- Proficient in speaking and writing the country language and English.
