Officer Job at Lambda | MPharm Graduates Apply Now
Lambda Therapeutic Research Ltd. is hiring an Officer for its Quality Assurance department in Ahmedabad, India. Offering a competitive CTC of ₹5,00,000 – ₹7,00,000, this Officer Job is designed for M.Pharm graduates with 2–3 years of experience in late-phase clinical trials. The successful candidate will conduct in-process, on-site, and off-site audits to ensure compliance with global regulatory, organizational, and client requirements, focusing on Clinical Data Management (CDM) and retrospective data reviews.
- Job Title: Officer
- Location: Ahmedabad, India
- Req ID: 1219
About The Company
Lambda Therapeutic Research is a global, full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With strategic facilities in the USA, Canada, UK, Poland, and Spain, Lambda provides comprehensive end-to-end clinical research services to global innovators, biotech, and generic pharmaceutical industries. The organization is dedicated to high-quality data and regulatory excellence across its global operations.
Organisational Overview
Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.
Job Details
To determine whether all trial-related activities were conducted, data recorded, analyzed, and reported accurately & in compliance with all applicable Regulatory requirements, Organizational requirements (Policy, Procedures, and processes), and Client’s requirements (protocol, contract, etc.) by routinely conducting audits (In process, on-site, and off-site) at various stages for all assigned projects.
- Performing & reporting of system audits as per the system audit annual calendar to ensure compliance w.r.to Lambda SOPs, Quality Systems, Protocol, and applicable regulatory requirements.
- To perform retrospective audits of study-related raw data like Informed Consent Forms, protocol, project management plan, and associated Plan, IMP plan, IMP release checklists, Safety Management Plan (SMP), Clinical Study Report,and Medical Imaging related documents.
- To assist in the completion of assigned system audits.
- Review of SOPs pertaining to Clinical Data Management (CDM) and preparation and review of SOPs pertaining to Quality Assurance.
- Audit of the clinical database and clinical data management documents (before database lock).
- Calculation of the % Error rate for the clinical database (before database lock) and issue the same to clinical data management. Prepare CDM audit status for incorporation in Audit Certificate/QA statement.
- Review of Data Management Plan (DMP), Statistical Analysis Plan (SAP-clinical data management aspects), and e-CRF/CRF design of projects in which clinical data management activities are undertaken at/by Lambda Therapeutic Research Ltd.
- Conduct a system audit of Clinical Data Management and prepare an audit report.
- Review of TMF, SMF, and Site selection visit report, IMP release checklist.
Educational Qualification
- M. Pharma
Experience
- 2-3 years in late phase QA is required for the MPharm Job
CTC Range (INR)
- Rs 500000 – 700000
