• Authorized end users to access Clinical Trial Data, Studies and Clinical Report Forms, Pharmacovigilance Data at various security levels depending on the user profile and designation.
• Provided support for Clinical Data Management software to Doctors, Scientists, Researchers, Lab Technicians.
• Documentation of work flow operations & formed report on daily basis for current and future activities using Microsoft office- Word and Excel.
• Applications Supported: OC – RDC (Oracle Clinical – Remote Data Capture), ClinTrial, ClinAdmin CREDI, REDI, PREDI, TEDI, TMS and DMS.

• Worked in Analytical Department with Lidocaine, Anesthetic Gel as drug candidate.
• Conducted Quality control tests on raw material and finished products.
• Operated instruments like HPLC, UV Spectrophotometer, Granulators, Mixers and tube filing and crimping machines
• Performed validation checks on distilled water equipment for accuracy and precision.
• Executed line clearance tasks in packaging and labeling department.
• Prepared Batch Manufacturing Records and assisted in reviewing Standard Operating Procedures.
• Assisted with sampling, warehousing, dispensing raw materials used in formulation.

Related Coursework:
Introduction to Drug and Medical Device Regulation, New Drug Development Biologics Development, Medical Device Development, Practical Aspects of Regulatory Affairs, Human Experimentation: Methodological Issues Fundamental to Clinical Trials, Managing International Clinical Trials, Food Drug and Medical Device Law

Related Coursework: Forensic Pharmacy and Drug Regulation, Hospital Pharmacy, Pharmaceutical Management, Pharmaceutics and Drug Delivery, Bio-pharmaceutics, Pharmacology, Medicinal Chemistry, Pharmaceutical Analysis, Biotechnology.