clinical data management

Job Description

JOB SUMMARY This position is responsible for assisting in all clinical data management activities required for clinical trials under supervision of more experienced Clinical Data Associates (CDAs). JOB RESPONSIBILITIES 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).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 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.For paper and hybrid studies, serve as back-up to data entry. Pre-review of CRFs (prior to scanning) and perform QC review of CRFs using an image system.For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems.Assists in tracking project progress and issuing periodic status reports.Participates in completion of all activities necessary for the finalization and transfer the clinical database and related project documents to the sponsor.Assists in identifying the achievement of milestones according to scheduled plans.Creates electronic storage media per standard operating procedures (SOPs) for EDC studies.Participates in internal meetings and in internal/external audits as required.Files documentation in the Data Management Study File (DMSF).Assists with study archival.Maintains proficiency in DM systems and processes through regular training courses (CDA Knowledge College).Understands the coding process.Understands the purpose of interim, dry run, data cut., QUALIFICATION REQUIREMENTS BA/BS degree in the biological sciences or related disciplines in the natural science/health care field.1 year of experience with DM practices and relational database management software systems preferred.Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred.Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills.Work experience in clinical research, drug development, data management, or other healthcare environment preferred.Familiarity with medical terminology.Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade.Good organizational, planning, and time management skills preferred. 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.Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%). Disclaimer

Keyskills :
clinical data managementcontrol roommusic makingelectronic data capturestandard operating procedurescase report formsdata managementdata trackingclinical datadatabase management system