Parexel | Jobs | Clinical Data Analyst II | BigDataKB.com | 19-02-22

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Job Location: India

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

  • Bachelorโ€™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

Apply Here

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