Job Summary

• A Site Manager serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines.
• Responsibilities include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring, and close-out activities, partnering with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Clinical Trial Manager (CTM).
• The role requires ensuring site staff are trained, study supplies are adequate, data entry and query resolution are timely, and all Adverse Events (AEs)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within required timelines.

Matching Summary

Skills & Requirements

Key Requirements

• BA or BS degree in Life Sciences, Nursing or related scientific field
• 1 year clinical trial monitoring experience preferred
• Strong working knowledge of GCP, company SOPs, local laws and regulations
• Proficient in speaking and writing country language and English

Work Rights