Clinical Data Analyst II Job Vacancy in Parexel India – Updated today
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Company Name : Parexel
Location : India
Position :
Job Description : Accountabilities: Demonstrates full competence when conducting the following tasks
Development of database build specificationsDevelopment of data validation specificationsTest data creation & UATPerforming/ leading functional QC activities and testingCreate CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.Data validation and cleaningConduct medical coding if assignedConduct SAE & third party data reconciliationsPerform early and final database QC activitiesDatabase lock activitiesMaintaining Clinical Study Documents and archiving as appropriate
Responsible for completeness, timely delivery and quality of clinical dataLearning role of Primary CDAAct as a single point of contact (internal expert) for specific processing task(s) on a projectSupport site monitoring personnel to retrieve missing data as requiredOther assigned responsibilities as needed SkillsStrong interpersonal, verbal and written communication skillsStrong technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS, MS-Office productsGood awareness of all relevant regulations, including ICH-GCP, 21 CFR 11Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG)Seeks opportunities to develop experience and knowledge in Clinical Trials and Pharmaceutical IndustryAbility to plan tasks and complete them within the appropriate timescale and to the required qualityAbility to work in team environment.Commitment and performs consistently high quality work Education
QualificationsBachelor’s degree and / or other medical qualification or relevant DM experience Language SkillsCompetent in written and oral English. Excellence in regional languages as needed. Minimum Work ExperienceMust 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
This post is listed Under Healthcare
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