Job Title: Officer – Quality Assurance (Clinical Research)
Job Category: Clinical Research / Quality Assurance / Clinical Data Management
Job Type: Full-Time
Location: Ahmedabad, Gujarat, India
Req ID: 1219
CTC Range: INR 5,00,000 – 7,00,000 per annum
Company Overview
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The organization delivers comprehensive end-to-end clinical research services to innovator, biotech, and generic pharmaceutical companies worldwide.
With operations spanning India, North America, and Europe, Lambda operates under globally recognized regulatory standards, ensuring compliance, data integrity, and operational excellence across clinical development programs.
Role Overview
We are seeking a detail-oriented Officer – Quality Assurance to support clinical research audits and quality systems within a regulated CRO environment. This role focuses on ensuring that clinical trial activities, documentation, and data management processes comply with regulatory requirements, organizational SOPs, and sponsor protocols.
The position is ideal for professionals with hands-on experience in late-phase QA audits, clinical data review, and system compliance within clinical research settings.
Key Responsibilities
Conduct in-process, on-site, and remote audits to ensure clinical trial activities are performed, recorded, analyzed, and reported in compliance with applicable regulatory guidelines, SOPs, and sponsor requirements.
Perform and report system audits as per the annual audit calendar to ensure adherence to internal quality systems and regulatory frameworks.
Execute retrospective audits of study-related documentation, including Informed Consent Forms (ICFs), protocols, project management plans, Investigational Medicinal Product (IMP) plans, Safety Management Plans (SMP), and Clinical Study Reports (CSR).
Review Trial Master File (TMF), Site Master File (SMF), site selection visit reports, and IMP release checklists for completeness and compliance.
Audit clinical databases and clinical data management documentation prior to database lock.
Calculate database error rates and communicate findings to the Clinical Data Management (CDM) team; prepare audit status reports for QA certification.
Review Data Management Plans (DMP), Statistical Analysis Plans (SAP – CDM aspects), and CRF/eCRF design for quality and compliance.
Conduct system audits of Clinical Data Management processes and prepare comprehensive audit reports.
Assist in the development, review, and updating of SOPs related to Clinical Data Management and Quality Assurance.
Required Experience
2 to 3 years of experience in late-phase Quality Assurance within clinical research, CROs, or pharmaceutical organizations.
Practical experience in clinical audits, database review, TMF audits, and regulatory compliance.
Strong understanding of ICH-GCP guidelines, clinical trial regulations, and data integrity principles.
Familiarity with Clinical Data Management systems and database lock procedures.
Excellent analytical, documentation, and reporting skills.
Educational Qualification
M. Pharm (Master of Pharmacy) or equivalent qualification in pharmaceutical sciences.
Professionals seeking to advance their careers in clinical research quality assurance and regulatory compliance are encouraged to apply through ThePharmaDaily.com for confidential consideration.
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