Associate Site Manager - Mumbai/bangalore/hyderabad/delhi
Johnson & Johnson Innovative Medicine
Bangalore, Karnataka, India
Fully remote
Good clinical practice (gcp)
Standard operating procedures (sop)
Clinical trial protocol compliance
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with clinical trial protocols, SOPs, GCP, and applicable regulations
Job Summary
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with clinical trial protocols, SOPs, GCP, and applicable regulations.
Responsibilities include assisting with site selection, qualification, subject recruitment, initiation, monitoring, and close-out activities, partnering with the Local Trial Manager and other team members.
The Associate Site Manager will ensure site staff are trained, data is accurate and complete, and all adverse events are reported within required timelines, while maintaining essential documents.
Matching Summary
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with clinical trial protocols, SOPs, GCP, and applicable regulations.
Skills & Requirements
Must-have
Good Clinical Practice (GCP)
Standard Operating Procedures (SOP)
clinical trial protocol compliance
site initiation and start-up
on-site and remote monitoring
site management and close-out
Nice-to-have
process improvement and training
therapeutic knowledge development
investigator meetings participation
risk-based monitoring implementation
Key Requirements
2-4 years on-site monitoring experience
Bachelors Degree (BSc) in life Sciences, Pharmacy, Medicine or related field