Job title: Clinical Data Analyst II
Job description: Accountabilities: Demonstrates full competence when conducting the following tasks . Development of database build specifications . Development of data validation specifications . Test data creation & UAT . Performing/ leading functional QC activitie
Accountabilities: Demonstrates full competence when conducting the following tasks . Development of database build specifications . Development of data validation specifications . Test data creation & UAT . Performing/ leading functional QC activities and testing . Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc. . Data validation and cleaning . Conduct medical coding if assigned . Conduct SAE & third party data reconciliations . Perform early and final database QC activities . Database lock activities . Maintaining Clinical Study Documents and archiving as appropriate . Responsible for completeness, timely delivery and quality of clinical data . Learning role of Primary CDA . Act as a single point of contact (internal expert) for specific processing task(s) on a project . Support site monitoring personnel to retrieve missing data as required . Other assigned responsibilities as needed Skills . Strong interpersonal, verbal and written communication skills . Strong technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS, MS-Office products . Good awareness of all relevant regulations, including ICH-GCP, 21 CFR 11 . Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG) . Seeks opportunities to develop experience and knowledge in Clinical Trials and Pharmaceutical Industry . Ability to plan tasks and complete them within the appropriate timescale and to the required quality . Ability to work in team environment. . Commitment and performs consistently high quality work Education Qualifications . Bachelor’s degree and / or other medical qualification or relevant DM experience Language Skills . Competent in written and oral English. Excellence in regional languages as needed. Minimum Work Experience . Must be able to demonstrate proficiency with several tasks included in data start-up through data-base lock. Previous relevant data management work experience required clinical and/ or research experience with solid understanding of clinical trials methodology and terminology required
Job date: Wed, 23 Feb 2022 23:36:40 GMT
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