Performs in compliance with Standard Operating Procedures(SOPs) / Work Instructions (WIs), regulatory directives, and study-
specific plans and guidelines.Performs essential functions which support database testing, Case Report Form (CRF) / electronic Case Report Form(eCRF) data review including query
creation, closure and requires as necessary and listingreview and quality control (QC) procedures including Data Management (DM) quality review for Ravestudies.
Essential Functions :
Maintains awareness of the pertinent elements of contract andscope of work for assigned project(s).
Reviews and adheres to the requirements of study-specific ClinicalData Management Plans for assigned project(s).
Generates and enters test data for user acceptance testing underguidance.
Receives and enters lab normal ranges.
Completes and submits Clinical Database Management System(CDMS)-specific access forms and / or spreadsheets.
Performs review of discrepancy (edit check) output and validationlistings based on data entered into the clinical database.
Based on thisreview, queries or applies self-evident corrections in cases where queries arenot required, per the Data Validation Specification (DVS) and / or DataManagement Plan (DMP)for the assigned projects.
Resolves answered queriescorrectly and re-queries where appropriate.
For paper studies, takes receipt of, and reviews, DataClarification Forms (DCFs) that have been answered by sites and whereappropriate, edits the Case Report Forms (CRFs) and database accordingly.
For paper studies, performs internal QC checks via listing outputfrom database against CRFs and DCFs.
For Rave studies, performs DM quality review and / or other internalQC checks as required per applicable Electronic Data Capture (EDC) systems.
For paper studies, ensures all CRFs and DCFs received are returnedfor filing in the Document Control Room (DCR) per the Data Tracking Guidelinesfor the assigned projects.
Runs data cleaning and / or status reports.
Creates electronic storage media per standard operating prodedures(SOPs) for EDC studies.
Participates in internal meetings and in internal / external auditsas required.
Files documentation the Data Management Study File (DMSF).
Maintains proficiency in DM systems and processes through regulartraining courses (CDA Knowledge College).
Graduate in biological sciences or related disciplines in thenatural science / health care field.
Min 5 to 7 yrs of Experience with DM practices and relationaldatabase management software systems. Oracle Clinical, Rave, orInform systems preferred.
Knowledge of medical terminology, clinical data, and ICH / GoodClinical Practices.
Proficiency in navigating MS Windows, as well as use of MS Word,Excel, PowerPoint and email applications.
Excellent speed and accuracy of keyboard skills.
Effective oral and written communication skills.
Good organizational, planning, and time management skills.
Ability to multitask under tight deadlines while providingattention to detail.
Ability to be flexible and adapt to change.
Ability to work independently as well as part of amulti-disciplinary team.