Clinical Research Associate
Minapharm Pharmaceutical
Total des années d'expérience :14 years, 7 Mois
Participated in monitoring study safety and handling data review and discrepancy resolution
Performed study initiation activities and reviewed protocols and regulatory issues
Assist Clinical Research Team in developing and writing clinical trial documents and manuals
1- Submission of Clinical Trials and contacting within Ministry of Health & Ethics commitee
2- Data Management for Clinical Trials
3- Writing & Reviewing Clinical Trials Protocols
4-The main person responsible for ensuring that the company (the product's Marketing Authorisation Holder or MAH) meets its legal obligations for the monitoring of the safety of a medicinal product on the market
5- Maintain safety of patients using Product company & efficacy of products
6- Creation of System Master File, Risk Management Plan, Periodic Benefit Risk Evaluation Report
7- Survey's for patients
8- awareness training for all employee for the pharmacovigilance important
1- The main person responsible for ensuring that the company (the product's Marketing Authorisation Holder or MAH) meets its legal obligations for the monitoring of the safety of a medicinal product on the market
2- Maintain safety of patients using Product company & efficacy of products
3- Creation of System Master File, Risk Management Plan, Periodic Benefit Risk Evaluation Report
4- Survey's for patients
5- awareness training for all employee for the pharmacovigilance important
Entering single, double and synchronizing data of the CRF using oracle medical life science, sending queries.
Responsible for the statistical integrity and accuracy of the clinical studies/databases using SPSS, providing guidance in statistical analysis methodology and performs statistical programming, design, and analyses for clinical trial projects. Plans, coordinates and provides statistical analyses, summaries and reports of studies
1- Pharmacovigilance System Master File 2- Periodic Benefit Risk Evaluation Report 3- Risk Management Plan 4- Biostatistics
Microsoft Database administrator 2008 Bio-statistical Diploma 2013