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Associate Site Manager

0-2 years
Not Disclosed
10 Sept. 25, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Site Manager

Location: Mumbai, India (Hybrid Work)
Function: R&D Operations
Sub-function: Clinical Trial Support
Category: Analyst, Clinical Trial Support (P4 – E24)
Requisition Number: R-034882
Date Posted: Sep 23, 2025


Company Overview

At Johnson & Johnson, we leverage healthcare innovation to prevent, treat, and cure complex diseases. Through our expertise in Innovative Medicine and MedTech, we deliver smarter, less invasive, and personalized healthcare solutions.

Learn more at: www.jnj.com


Position Summary

The Associate Site Manager is an entry-level site management role (0-2 years experience, or 3-4 years for Study Coordinators) responsible for serving as the primary contact between the Sponsor and investigational sites. The role ensures inspection readiness and compliance with clinical trial protocols, company SOPs, GCP, and applicable regulations from site start-up to close-out.

This position focuses on centralized in-house site management and oversight, including regulatory compliance, site initiation, and trial-related activities, with guidance from a Lead/Senior Site Manager.


Key Responsibilities

1. Site Management & Monitoring

  • Serve as the primary local contact for assigned trial sites.

  • Assist with site selection, feasibility, and site qualification visits.

  • Participate in investigator meetings as required.

  • Execute site initiation, start-up, monitoring (on-site and remote), site management, and close-out activities in compliance with SOPs, Work Instructions, and company policies.

  • Implement analytical risk-based monitoring and ensure timely resolution of monitoring findings.

  • Ensure site staff are trained, and training records are complete and accurate throughout the trial.

2. Recruitment & Study Conduct Support

  • Contribute to site-level recruitment strategy and contingency planning.

  • Ensure clinical trial supplies (IP, lab kits, etc.) are adequate, properly handled, stored, and documented.

  • Oversee data entry, query resolution, and accuracy, validity, and completeness of trial data.

  • Ensure timely reporting and documentation of AEs, SAEs, and PQCs.

3. Documentation & Compliance

  • Maintain complete and accurate trial records in relevant systems.

  • Document trial-related activities, including monitoring visit reports and follow-ups.

  • Review study files for completeness and adherence to archiving and retention requirements.

  • Ensure CAPAs are completed for QA site audits and quality issues identified during monitoring.

  • Support regulatory submissions (HA, IEC/IRB) as needed.

4. Stakeholder Management & Collaboration

  • Collaborate with LTM, CTA, TDL, trial central teams, and other stakeholders.

  • Maintain positive relationships with investigators, trial coordinators, and site staff.

  • Track site-level costs and ensure timely payments, if applicable.

5. Process Improvement & Training

  • Contribute to process improvement initiatives and training activities.

  • Act as a local expert in assigned protocols and develop sufficient therapeutic knowledge to support the role.


Education & Experience Requirements

  • Education: BA or BS in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience).

  • Experience:

    • Minimum 1 year of clinical trial monitoring experience (1-2 years preferred).

    • Experience with site qualification visits and centralized start-up activities.

    • Familiarity with GCP, SOPs, local regulations, protocol-specific procedures, and monitoring guidelines.

    • Regulatory experience (eSUGAM), import/export requirements for clinical trials.

  • Skills:

    • Strong IT skills and proficiency in company software systems.

    • Excellent written and oral communication in English and local language.

    • Willingness to work in-house with occasional guidance from senior staff.


Work Environment

  • Centralized in-house role (no travel to sites required).

  • Hybrid work model.

  • Fast-paced, team-oriented environment focusing on clinical trial start-up and oversight.


Principal Relationships

  • Reports To: FM/CRM

  • Primary Interfaces: FM/CRM, CTA, LTM, TDL

  • Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Compliance Managers/Specialists, Training Manager, CCS, Local Safety Officer, Site Manager team

  • External Interfaces: Investigators and their delegates at trial sites