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Currently working as a clinical data analyst in Parexel International, Hyderabad
Total 6 years of working experience.
Previously worked as a quality reviewer in healthcare industry.
Also worked as quality research associate in a clinical trial organisation.
Specialties: Drug development process, Clinical trial operation, quality assurance, Training management, Clinical data analysis and management
Data quality analysis, ensuring data accuracy and completeness, attention to details of data for annual and interim report, trend analysis, User acceptance testing on database, external client interaction, working under tight deadlines,
teaching students on good clinical practice, essential documetns in clinica trials, clinical trial supply chain management, investigator's brochure.
Reviewing clinical trial documents, providing expert comments based on regulatory compliance norms
Reviewing clinical trial data and generating DCF. Coordinating with CRAs for resolving the discrepancies.
SOP writing, reviewing and management, clinical trial document control and retention.
Managing clients at front end, clarifying technical issues, representing company to sponsor and auditor as a management representative.
Preparation of quality documents such Quality Manual, Training Manual. And other standard documents and forms used in clinical trials.
Internal audit, trail site audit, vendor audit and evaluating non conformity following to audit, suggesting CAPA. Ensuring the accomplishment of corrective actions in time.
Experienced in ISO auditing and documentation.
Experienced in investigator site audit for Phase III and IV clinical trials
Internal staff audit & training
External vendor audit such as clinical Lab
Preparing clinical trial document such as protocol, CRF, ICD, CSR, regulatory documents
Coordinating with ethics committee for submission and approval of trial documents
Preparing site feasibility questionnaire, selection of site, selection of investigator
Coordinating with trial site, trial site initiation, trial site training
Trial site monitoring, CRF review, drug accountability
Maintaining trial site master file
Coordinating with auditor and quality assurance team and supporting them in every quality assurance activities
Lecturer in Biotech division.
Somnia Anesthesia Solution
- SIX-sigma, green belt
- PG certificate in Clinical Trial Management
- Clinical Data Management
- Medical Writing
- CLINICAL TRIAL AUDITING
- QUALITY ASSURANCE...
- Drug Development
- Data Management
- Quality Assurance
- Clinical Monitoring
- Data Analysis
- Six Sigma
- ISO 9001 2008
- Essential documents in...
- TMF and ISF filing
- Clinical trial supply...
- See 6+ See less
Genotypic characterization of Escherichia coli
Text book - Microbial Biotechnology: Methods and Applications
- clinical research,
- clinical data management software,
- clinical trial auditing,
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