Johnson & Johnson is recruiting for the position of Sr. Site Manager based in Mumbai and Hyderabad, India. The company believes health is everything and utilizes its expertise in Innovative Medicine and MedTech to deliver healthcare solutions. This recruitment offers professionals an opportunity to impact health for humanity through clinical trial support.
Job Overview
The Senior Site Manager acts as the primary contact point between the Sponsor and the Investigational Site. This mid-level site management role, falling under R&D Operations and Clinical Trial Support, typically requires 3-5 years of experience. The selected candidate will ensure inspection readiness by complying with clinical trial protocols, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations from study start-up through to site closure. This position operates on a hybrid work pattern.
Important Dates
- Application End Date: 31st March 2026
Eligibility Criteria
- Experience: Typically requires 3-5 years of experience in a relevant field.
- Knowledge: Must possess proficient therapeutic knowledge sufficient to support the role and act as a local expert in assigned protocols.
- Preferred Skills: Clinical Data Management, Clinical Trials Operations, Laboratory Operations, Regulatory Environment, Regulatory Inspections, Research and Development, Research Ethics, Study Management, Execution Focus, Problem Solving, Process Improvements, Project Support, Time Management, Business Behavior, Business English, Mentorship, and Proactive Behavior.
Key Responsibilities
- Act as the primary local company contact for assigned sites for specific trials.
- Execute activities within site initiation, start-up, site monitoring (on-site and remote), site management, and site/study close-out according to SOPs and policies.
- Ensure site staff are trained and corresponding training records are complete and accurate during all trial phases.
- Contribute to site-level recruitment strategy and contingency planning.
- Ensure site study supplies and clinical drug supplies are adequate, appropriately handled, stored, and returns are documented.
- Ensure site staff complete data entry and resolve queries within expected timelines, ensuring accuracy and validity of collected data.
- Proactively ensure that all Adverse Events (AE), Serious Adverse Events (SAEs), and Product Quality Complaints (PQCs) are reported within required timelines.
- Maintain complete, accurate, and timely data and essential documents in trial management systems.
- Fully document trial-related activities, particularly monitoring, and write visit reports in accordance with SOPs.
- Collaborate with the Local Trial Manager (LTM) for documenting and communicating site/study progress and issues.
- Work closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for audits and quality issues.
- Prepare trial sites for close-out and conduct final close-out visits.
- Establish and maintain good working relationships with investigators, trial coordinators, and other site staff.
- May participate in Health Authority (HA) and IEC/IRB submission processes.
- May serve as a coach and mentor to less experienced site managers and contribute to process improvement and training.
How to Apply
Interested and eligible candidates can apply online for the Sr. Site Manager position with requisition number R-061437 through the official career portal.
Official Notification & Links
Important Instructions
- The Senior Site Manager is generally expected to operate independently with little or limited supervision.
- This role is categorized under Experienced Analyst, Clinical Trial Support (P5).
- The work location includes Mumbai, Hyderabad, and India with a hybrid work pattern.
Conclusion
Eligible candidates with the required experience in clinical trial operations and site management are encouraged to review the details and apply before the specified end date. This is an excellent opportunity to join a leading healthcare innovation company.
