Johnson & Johnson is hiring for an Associate Site Manager position in Mumbai, India. The role is an entry-level site management position supporting clinical trials from study start-up through site closure, with responsibilities across site monitoring, compliance, recruitment, data quality, safety reporting, and trial documentation.

Job Details

Position

Associate Site Manager

The Associate Site Manager serves as a primary contact between the sponsor and investigational sites, supporting clinical trial activities while ensuring compliance with protocols, SOPs, GCP, regulations, and applicable guidelines.

Responsibilities

• Act as the primary local company contact for assigned clinical trial sites.
• Participate in site feasibility and Site Qualification Visits.
• Participate in investigator meetings.
• Execute site initiation, start-up, monitoring, site management, and close-out activities.
• Conduct remote monitoring and implement analytical risk-based monitoring at site level.
• Ensure timely resolution of monitoring issues.
• Ensure site staff training records are complete and accurate.
• Support site activation activities with the Local Trial Manager and study team.
• Contribute to site recruitment strategies and contingency planning.
• Ensure adequate site study supplies.
• Ensure clinical drug supplies are appropriately handled, stored, returned, and documented.
• Ensure timely data entry and query resolution.
• Ensure accuracy, validity, and completeness of clinical trial data.
• Ensure AE, SAE, and PQC reporting within required timelines.
• Maintain essential trial documents and data in relevant systems.
• Prepare monitoring visit reports and follow-up letters.
• Review study files and ensure archiving requirements are met.
• Collaborate with the Local Trial Manager on site and study progress.
• Participate in team meetings and training.
• Develop therapeutic knowledge relevant to assigned protocols.
• Support CAPA completion for site audits and quality issues.
• Prepare sites for close-out and conduct final close-out visits.
• Track site-level costs and payments, where applicable.
• Maintain relationships with investigators, trial coordinators, and site staff.
• Support Health Authority and IEC/IRB submissions and notifications when required.
• Contribute to process improvement and training.

Eligibility / Qualifications

• Minimum BS degree in Pharmacy, Nursing, Life Sciences, or a related scientific field, or equivalent experience.
• Minimum 1 year of clinical trial monitoring experience.
• 1–2 years of clinical trial monitoring experience is preferred.
• Other relevant experience and skills may be considered by the hiring manager.
• Demonstrated AI literacy and an AI-enabled mindset.
• Basic knowledge of GCP, company SOPs, local laws, regulations, assigned protocols, and monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel, including occasional overnight stays.
• Proficiency in the country language and English.
• Good written and oral communication skills.
• Specific therapeutic area experience is an added advantage.

Required Skills

• Analytical Reasoning
• Clinical Data Management
• Clinical Trials
• Clinical Trial Operations
• Clinical Study Management
• Issue Escalation
• Project Support
• Regulatory Environment
• Research Ethics
• Process Improvement
• Time Management
• Laboratory Operations
• Execution Focus
• Strong Communication
• AI Literacy

Application Details

Position: Associate Site Manager
Company: Johnson & Johnson
Location: Mumbai, India
Work Model: Hybrid Work
Experience: Minimum 1 year of clinical trial monitoring experience
Application Deadline: October 15, 2026
Requisition ID: R-103409

Application Link