Job Title: Associate Site Manager
Req ID: R-034882
Function: R&D Operations
Sub-Function: Clinical Trial Support
Category: Analyst, Clinical Trial Support (P4 – E24)
Location: Mumbai, India
Work Pattern: Hybrid
Posted On: September 23, 2025
Job Purpose
The Associate Site Manager is an entry-level site management role, serving as the primary contact between the Sponsor and Investigational Site. This role ensures inspection readiness and compliance with clinical trial protocols, SOPs, GCP, and applicable regulations from site start-up through closure. Responsibilities may include site selection, qualification assessment, subject recruitment, site initiation, monitoring (on-site and remote), and close-out activities. The Associate Site Manager collaborates with Local Trial Manager (LTM), Clinical Trial Assistant (CTA), and Trial Delivery Leader (TDL) to support trial management and may contribute to process improvements and training.
Principal Responsibilities
Site Management & Monitoring
Act as primary local company contact for assigned sites.
Participate in site feasibility and/or qualification visits.
Attend investigator meetings as required.
Execute site initiation, monitoring (including remote), and close-out activities per SOPs, Work Instructions (WIs), and policies.
Implement analytical risk-based monitoring at the site level and ensure timely resolution of issues.
Ensure site staff are trained; maintain accurate training records throughout trial phases.
Contribute to recruitment strategy and contingency planning in partnership with functional areas.
Ensure study supplies (IP, lab kits, etc.) are adequate, properly handled, stored, and returned or destroyed as appropriate.
Ensure timely and accurate data entry, query resolution, and AE/SAE/PQC reporting.
Maintain complete and accurate trial documentation, including monitoring visit reports and follow-up letters.
Review study files for completeness and ensure archiving and retention requirements are met.
Collaboration & Communication
Work with LTM to document and communicate site/study progress and issues.
Participate in team meetings and trainings; provide feedback and leadership when required.
Develop therapeutic knowledge sufficient to support assigned protocols.
Work with LTM to ensure CAPA completion for QA site audits and other quality issues.
Maintain good working relationships with internal stakeholders (R&D Country Head, TA Manager, Compliance Managers, Training Manager, CCS, Local Safety Officer) and external stakeholders (investigators, trial coordinators, site personnel).
Operational Oversight
Track site-level costs and ensure payments are made when applicable.
Ensure compliance with Health Authority (HA) and IEC/IRB submissions, as required.
Contribute to process improvements and training activities.
Prepare sites for close-out and conduct final close-out activities.
Education & Experience Requirements
Minimum BA/BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field (or equivalent experience).
Minimum 1 year of clinical trial monitoring experience; 1–2 years preferred.
Experience in regulatory compliance, eSUGAM completion, import/export requirements, and site qualification visits is an advantage.
Basic working knowledge of GCP, company SOPs, local laws, and regulations.
Strong IT skills and proficiency in company software and systems.
Excellent written and oral communication skills in English and the local language.
Willingness to travel occasionally for overnight stays (though the role is primarily in-house).
Key Interfaces
Primary Reporting: FM/CRM
Internal: LTM, CTA, TDL, R&D Country Head, TA Manager, Compliance Managers, Training Manager, CCS, Local Safety Officer, Site Manager Team
External: Investigators and their site delegates
Work Environment & Conditions
Hybrid in-house role; minimal site travel required.
Centralized responsibilities including start-up activities and in-house site management and oversight.
Gujarat :
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