Cliantha Research, a leading life science company, is a global full service Contract Research Organization with integrated offerings in Clinical, Bioanalytical, Dermatology, Biometrics, Pathology and Formulation services.
Position : QAQC/ QC-clinic
Duration : 0 – 1 years
Location : Ahmedabad
Desired Profile : B.Pharma – Pharmacy | M.Pharma – Pharmacy
Job Summary :
- Review of Clinical Raw Data, Review of Clinical Study Report, Online monitoring of study and Archiving of Study.
- BASIC SKILLS AND ABILITIES: Knowledge of GCP, ICH E3 and Regulatory Guidelines.
Principal Duties :
- Online monitoring of studies to ensure that studies are conducted in accordance with GCP, SOPs, Protocol and regulatory guidelines.
- Review 100% of clinical raw data for completeness, accuracy, and for compliance with the Study Protocol, GCP, SOPs and applicable Regulatory Guidelines.
- Review of Clinical Study Report as per ICH (E3), protocol, clinical raw data, sponsor and regulatory requirements.
- Reconciliation and accountability of issued forms for specific studies.
- Preparation of projects for QA audit and Archiving.
- Review of Quality Control-Clinic SOPS
- Issuance of Forms
- QC Checks of Randomization and actual time point data prepared by PKBS
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