Associate Site Manager - Mumbai/bangalore/hyderabad/delhi
Johnson & Johnson
Bangalore, Karnataka, India
Fully remote
Good clinical practice (gcp)
Clinical trial protocol compliance
Site initiation and start-up
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and regulations
Job Summary
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and regulations.
Responsibilities include site selection, qualification, subject recruitment, initiation, monitoring (on-site and remote), and close-out activities, partnering with LTM, CTA, and TDL.
The Associate Site Manager will ensure site staff are trained, data entry and query resolution are timely, and all essential documents are maintained accurately and archived appropriately.
Matching Summary
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with protocols, SOPs, GCP, and regulations.
Skills & Requirements
Must-have
Good Clinical Practice (GCP)
clinical trial protocol compliance
site initiation and start-up
site monitoring and close-out
adverse event reporting
Nice-to-have
process improvement and training
therapeutic knowledge development
stakeholder relationship management
Key Requirements
2 - 4 years on-site monitoring experience
Bachelors Degree (BSc) in life Sciences, Pharmacy, Medicine or related field