Job Title: Senior Site Manager
Locations: Mumbai, MH / Penjerla, Telangana / Bangalore, KA, India
Function: R&D Operations
Sub-Function: Clinical Trial Support
Category: Experienced Analyst, Clinical Trial Support (P5)
Date Posted: Sep 15, 2025
Requisition Number: R-022843
Work Pattern: Hybrid
Company Overview:
At Johnson & Johnson, we believe health is everything. Leveraging expertise in Innovative Medicine and MedTech, we aim to prevent, treat, and cure complex diseases with smarter, less invasive, and personalized healthcare solutions. Learn more at www.jnj.com.
Role Summary:
The Senior Site Manager is a mid-level clinical site management role with 3–5 years of clinical monitoring experience. The role serves as the primary contact between the Sponsor and the Investigational Site, ensuring inspection readiness and compliance with clinical trial protocols, company SOPs, Good Clinical Practice (GCP), and applicable regulations throughout the study lifecycle—from site start-up to site closure.
Key Responsibilities:
Site Management & Compliance:
Serve as the primary liaison between Sponsor and Investigational Site.
Ensure sites are inspection-ready and comply with clinical trial protocol, SOPs, GCP, and regulations.
Assist with site selection, qualification assessment, initiation, monitoring (on-site & remote), subject recruitment, retention planning, and site close-out activities.
Maintain accurate records and documentation, including safety-related events and investigational product assessments.
Trial Execution Support:
Support start-up, execution, and completion of clinical research studies while ensuring subject safety and confidentiality.
Document site visits and trial observations, identifying opportunities to improve outcomes.
Gather data on the clinical trial environment and measure against key performance indicators.
Observe and train patients on trial purpose and outcomes in compliance with regulatory requirements.
Team Leadership & Development:
Partner with Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Trial Delivery Leader (TDL) to manage assigned trial sites.
Coach junior colleagues in clinical trial techniques, processes, and responsibilities.
Contribute to process improvement initiatives and support mentoring of other Site Managers.
Operational Excellence:
Act as a point of contact for the clinical trial team and escalate issues as required.
Operate independently with minimal supervision.
Apply Johnson & Johnson’s Credo and Leadership Imperatives in daily interactions with teams and stakeholders.
Qualifications & Experience:
3–5 years of clinical monitoring experience.
Strong understanding of GCP, SOPs, clinical trial protocols, and regulatory requirements.
Excellent communication, interpersonal, and documentation skills.
Ability to work independently and as part of cross-functional teams.
This structured format highlights role, responsibilities, and qualifications clearly for candidates and job portals.
Gujarat :
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