Contract Compliance Specialist
Advanced Clinical - Exton, PA

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Job Number: 411406

Contract Compliance Specialist

Minimum Requirements:

Education: Bachelor's or professional allied health degree required;

Knowledge Requirements: *
  • Must be proficient with applicable GCP/ICH, regulatory requirements, and industry data management standards *
  • Strong attention to detail, good organizational skills, ability to work independently
Experience: *
  • 6-8 years minimum experience in clinical data management *
  • Must have experience with all clinical data review processes including query generation/ resolution, reconciliation, closeout procedures, and applicable documentation of data management processes *
  • Must have experience with EDC systems *
  • Oncology experience required

Job Description:


Primary responsibility for clinical data review, query generation / resolution, coding, and data reconciliation tasks to support the delivery of clinical data



Facilitates the set-up of clinical data management for studies including CRF/ eCRF development, database set-up, workflows, and creating Data Management Plans including data specifications and data review guidelines



Reviews clinical trial data in accordance with Data Management Plans and applicable standardized data management processes to identify erroneous, missing, or incomplete data.

15% 4.

Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the on-going review of clinical trial data

15% 5.

Generate, resolve and track queries to address problematic data identified during data review activities



Perform reconciliation of the clinical and safety databases and third party vendor data (eg central laboratory, etc.)



Supports clinical teams in the management of interim and final project milestones including facilitating aspects of database lock



Contributes to continuous process improvement within data management including input into workflows and SOPs


Interested candidates please send resume in Word format to Please reference job code 411406 when responding to this ad.

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