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:

1.

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

15%

2.

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

15%

3.

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

10%

6.

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

10%

7.

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

10%

8.

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

10%

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

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