A Site Manager II serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and applicable regulations
Job Summary
A Site Manager II serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and applicable regulations.
Responsibilities include assisting with site selection, subject recruitment and retention planning, site initiation, monitoring, and close-out activities, partnering with LTM, CTA, and CTM for overall site management.
The role requires strong working knowledge of GCP, company SOPs, local laws and regulations, and proficiency in speaking and writing the country language and English.
Matching Summary
A Site Manager II serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and applicable regulations.
Skills & Requirements
Must-have
Site management
Clinical trial protocol compliance
GCP and regulatory adherence
Subject recruitment and retention
Site initiation and close-out
Data entry and query resolution
Adverse event reporting
Nice-to-have
Process improvement contributions
Mentoring experience
Therapeutic area expertise
Health Authority submissions
Key Requirements
BA or BS degree in Life Sciences or related field
2 years clinical trial monitoring experience preferred
Proficient in speaking and writing country language and English