Pharma Job : Clinical Data Coordinator Post Vacant @ Covance

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Covance
Solutions Made Real

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

Job Title  Clinical Data Coordinator

Job Number : 2018-17766

Job Description:

  • 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.

Qualifications

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Education/Qualifications

Minimum Required

  • University / college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g.nursing certification, medical or laboratory technology)
  • In lieu of the above requirement, approximately 18 months experience in related field (e.g. pharmaceutical, laboratory, data analysis) incorporating approximately one year’s clinical data management experience will be considered.
  • Knowledge of drug development process.
  • Knowledge of effective clinical data management practices
  • Knowledge of ICH guidelines and GCP including regulatory requirements for the conduct of clinical development programs.

Preferred

  • Knowledge of Covance and the overall structure of the organization.
  • Knowledge of Covance standard operating procedures.

Experience
Minimum Required

  • Minimum 1 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.

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