Job Title: Officer – Quality Assurance (Clinical Research)**
Req ID: 1219
Location: Ahmedabad, Gujarat, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 5,00,000 – 7,00,000 per annum
Experience Required: 2–3 years of experience in Late-Phase Quality Assurance (QA) within clinical research
Job Type: Full-Time | On-Site | Permanent
Job Category: Quality Assurance | Clinical Data Management | Clinical Research | CRO Operations
About the Company
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), the organization delivers comprehensive end-to-end clinical research services to innovators, biotechnology companies, and generic pharmaceutical organizations worldwide.
The company operates across Phase I–IV clinical trials with strong regulatory, quality assurance, and clinical data management capabilities.
Role Overview
The Officer – Quality Assurance will be responsible for conducting audits to ensure that clinical trial activities, data management processes, and regulatory submissions are performed accurately and in compliance with applicable regulatory requirements, organizational SOPs, and sponsor protocols.
This role requires expertise in late-phase QA, system audits, clinical data management review, and regulatory compliance within a CRO environment.
Key Responsibilities
Conduct in-process, on-site, and off-site audits across assigned clinical projects to ensure compliance with regulatory, organizational, and client requirements
Verify that trial-related activities, data recording, analysis, and reporting meet applicable regulatory standards and protocol requirements
Perform and report system audits as per the annual audit calendar
Conduct retrospective audits of study-related raw data including:
Informed Consent Forms (ICFs)
Clinical protocols
Project Management Plans and associated documents
Investigational Medicinal Product (IMP) plans and release checklists
Safety Management Plans (SMP)
Clinical Study Reports (CSR)
Medical imaging documentation
Assist in the execution and closure of assigned system audits
Review SOPs related to Clinical Data Management (CDM) and support the preparation and revision of QA-related SOPs
Audit clinical databases and CDM documentation prior to database lock
Calculate and report error rates in clinical databases before lock
Prepare CDM audit status reports for inclusion in Audit Certificates or QA statements
Review Data Management Plans (DMP), Statistical Analysis Plans (SAP – CDM aspects), and CRF/e-CRF design documentation
Conduct system audits of Clinical Data Management functions and prepare detailed audit reports
Review Trial Master Files (TMF), Site Master Files (SMF), site selection visit reports, and IMP release documentation
Required Experience
2–3 years of hands-on experience in Late-Phase Quality Assurance within clinical research
Experience in clinical trial audits, regulatory inspections, and compliance verification
Exposure to Clinical Data Management processes and database audits
Strong understanding of ICH-GCP guidelines and global regulatory requirements
Ability to review technical documentation including DMP, SAP, TMF, and CSR
Educational Qualifications
M. Pharm (Master of Pharmacy) – Mandatory
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