Job Title:  Officer

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a full-service Global Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), Warsaw (Poland) and London (UK), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

Department : Late Phase Quality Assurance

Designation: Officer/Sr Officer

Role: Clinical Data Management Auditor

Experience 4-8 years:

Education: M.Pharm/B.Pharm

Salary: around 8 L

Job Description:

• To determine whether all trial related activities were conducted, data recorded, analyzed and reported accurately & in compliance to 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 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, Medical Imaging documents.
• 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 % 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 System audit of Clinical Data Management and preparation of audit report.
• Review of TMF, SMF and Site selection visit report, IMP release checklist.

COMPETENCIES