AHMEDABAD · FULLTIME
Executive
Lambda Therapeutic Research
Ahmedabad · onsite · Posted 13d ago
Sourced from
Undisclosed3–8 yrsfulltimeAhmedabad
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Section · 01
About this role
- Plan and carry out In-process audits of study activities in Clinical Pharmacology Medical Affairs department like Alco/Urine scan, informed consent presentation, compliance check, check-in, dosing, meal distribution, phlebotomy, dispensing, Sample separation etc.
- Conduct retrospective audits of study related raw data like Informed Consent Forms, Medical Screening records, Trial Master File, Investigation Medicinal Product forms, Clinical raw data like Case Record Forms, General Case Record Forms, listings in case of e-CRF studies, PK PD Projects etc.
- Review of Clinical Pharmacology and Medical Affairs, Quality Assurance, Biostatistics Programming and other cross functional department SOPs for correctness, adequacy and completeness.
- Conduct retrospective review of Clinical Study Report, PK/statistical study report and clinical study protocol.
- Conduct system audit as per schedule, preparation of audit report and ensuring compliance in Clinical Pharmacology Medical Affairs, Biostatistics Programming and other cross functional department.
- Review of incident report, investigation report, Statistical Analysis Plan (SAP) or other study specific documents.
- Review of sponsor comments Monitoring observation responses.
- Conduct the dossier verification for correctness and completeness.
- Preparation of Audit Certificate/Quality Assurance Statement.
- Uploading of QA related documents in e-TMF software.
- Review of uploaded data in e-TMF software.
- Conduct the vendor audits who are service providers to assess compliance.
- Providing support in sponsor and regulatory inspections.
- To perform QA functions as per OECD GLP principles and to ensure its compliance.
- Any other responsibilities as assigned by the management / HOD.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
QASAPDossierpharmacologymedical affairsauditsphlebotomyProgrammingstatistical analysissystem auditClinical PharmacologyDispensingclinical study reportQuality AssuranceAudit Reportcompliance
Section · Company
About Lambda Therapeutic Research
Lambda Therapeutic Research
Clinical Research
1.0k+
employees
1999
27 years old
Ahmedabad, Gujarat
IN
₹7.3L PA avg
Avg at Lambda Therapeutic Research
About
Lambda Therapeutic Research is a full-service Global CRO, headquartered in Ahmedabad, with presence in Mehsana (India), USA, Canada, UK, Spain & Poland.
Industries
Clinical ResearchPharma
Employee ratings
10 reviews
4.1/ 5
Culture
2.7
Career growth
3.0
Work-life
2.9
Employees rate it well for
Compensation & Benefits42Skill Development42
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