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Keywords / Skills : Clinical Data Coordinator, Clinical Trials Data, Ancillary programs

3 - 7 years
Posted: 2019-05-17

Job Description
Clinical Data Coordinator

Job Overview 

Work Location : Bangalore

Serve as a member of the project team with Primary responsibility for clinical data review, query generation / resolution and reconciliation to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets.

Essential Job duties
  • Review clinical trial data in according with Globasl data Management plan and applicable standardized data management processes to identify erroneous, missing, incomplete, or implausible data.
  • Run ancillary programs (e.g. Diagnostics, special listings, reconciliation discrepancy listings) used to ussport the review of clinical trial data.
  • Generate, resolve and track queries to address problematic data idetified during data review activities and apply proper modification / correction to the database.
  • Apply quality control procedure and checks to ensure data quality standards(client and covance) are achieved.
  • Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application.
  • Assist with the reconciliation of central laboratory and / or third party vendor data (eCRF, edDiary, specialty laboratory, etc.)
  • Assist with the aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation.
  • Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special lisitings / procedures used as tools for the data review and discrepancy management activities.
  • Support the training of project staff on project-specific, global standardized data management processes.
  • Perform other duties as assigned by management.


Education/Qualifications


Education:


Graduate or Bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college

Experience 

Minimum Required
  • Minimum 3 to 7 year of relevant work experience with increasing responsibility in data management with knowledge of 1 or more therapeutic areas.
  • Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.
  • Demonstrated ability to work in a team environment and collaborate with peers.
  • Demonstrated interpersonal skills.
  • Good oral and written communication skills.



About Company

Covance India Pharmaceutical Services Private Limited
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