Phase 2-4 clinical trials.From study start up to study closure.

Defining programs, projects and appropriate compounds assigned to the program.Creating organization units, planned studies and defining regions.Defining easy study design by creating intervals, clinical planned events, treatments and creating patient positions and displaying the exited patientsMaintain the investigator records by creating investigator records and assigning investigator to study sites. Creating DVGs, adding values to DVG, creating DVG subsets, activation of DVG's and adding the activated DVGs to questionsCustomizing data entries screens and transfer the data entry forms into production data entry.Creating, copying, activating and associate the activated DCMs with DCIs and prepare the DCI books.Data entry, first pass, second pass, test data entry, reconciling the differences between the first pass and second pass data entry and transfer the data from test data to production data entry.Managing, resolving univariate, multivariate, indicator and manual discrepancies in the discrepancy data base.Creation and obsolesce discrepancies by running the batch validation process and review the result of batch validation. Creating DCFs, adding, removing and editing DCFs discrepancies and printing the data clarification forms and sent to investigators. Validating and deriving the patient data by using validation and derivation procedures.Freezing and unfreezing the data, locking the database by batch locking and manually locking the RDCIs and RDCMs.ADDITIONAL SKILLS :Data bases : Oracle Clinical 4.5.3.Languages : SQL, PL/SQL.SQL Server.Operating System : Windows 98/2000/XP professional. Packages : MS-OFFICE1; I have undergone rigorous training in Oracle clinical (4.5.3), did project on phase III trial using oracle clinical tool as a part of internship program.