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 listing review and quality control (QC) procedures including Data Management (DM) quality review for Rave studies.
Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).
Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
Generates and enters test data for user acceptance testing under guidance.
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 validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections in cases where queries are not required, per the Data Validation Specification (DVS) and/or Data Management Plan (DMP)for the assigned projects. Resolves answered queries correctly and re-queries where appropriate.
For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the Case Report Forms (CRFs) and database accordingly.
For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs.
For Rave studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems.
For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room (DCR) per the Data Tracking Guidelines for 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 audits as required.
Files documentation the Data Management Study File (DMSF).
Maintains proficiency in DM systems and processes through regular training courses (CDA
Graduate in biological sciences or related disciplines in the natural science/health care field.
Min 5 to 7 yrs. of Experience with DM practices and relational database management software systems. Oracle Clinical, Rave, or Inform systems preferred.
Knowledge of medical terminology, clinical data, and ICH/Good Clinical 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 providing attention to detail.
Ability to be flexible and adapt to change.
Ability to work independently as well as part of a multi-disciplinary team.
Salary: ₹ Pharma / Biotech / Clinical Research
Industry: Healthcare & Medicine
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