Clinical Data manager

The Fountain Group is currently seeking a Clinical Data manager for a prominent client of ours. This position is located at Durham, NC. Details for the position are as follows:

Job Title: Clinical Data Manager

Location: Bldg 4201 - GSSNA, Durham, NC

Pay Rate: $55-65/hr

Duration: 9-month contract with strong extension potential

Job Description

The Clinical Data Manager will support clinical research data management activities including clinical data review, database validation, query management, and study closeout activities. This role will collaborate with CROs and internal study teams to ensure data quality, integrity, and compliance throughout the clinical trial lifecycle.

• Perform User Access Management in Veeva Vault EDC
• Create specifications for data review listings and custom listings in Veeva Vault CDB
• Execute User Acceptance Testing (UAT) in Veeva Vault EDC and CDB; document and track findings through resolution
• Design and validate CRFs, clinical databases, and edit checks
• Develop project-specific eCCG and Data Management Plans
• Generate and manage data queries based on validation checks and data review findings
• Design Data Transfer Specifications (DTS) for clinical data processing and tracking
• Process clinical data transfers including receipt, verification, and reconciliation
• Perform quality control audits to ensure clinical data accuracy and system compliance
• Provide oversight and QC review of CRO data management deliverables
• Support database lock activities and study closeout troubleshooting
  
  

Education

• Bachelor’s degree in Management Information Systems, Computer Science, Life Sciences, or related field required
• Equivalent clinical data management experience will be considered
  
  

Required Skills

• Clinical Data Management experience in clinical research environments
• Hands-on experience with Veeva Vault EDC and Veeva Vault CDB
• Extensive clinical data review and query management experience
• Experience designing and validating CRFs and edit checks
• Database lock and study closeout experience
• User Acceptance Testing (UAT) for EDC systems
• Data Transfer Specification (DTS) development and data reconciliation
• Experience working with CROs and outsourced data management activities
• Knowledge of eCCG and Data Management Plan development
• Clinical database validation and quality control auditing
• EDC administration and user access management
  
  

Preferred Skills

• Experience supporting Phase I-III clinical trials
• Knowledge of clinical data coding and reporting processes
• Familiarity with GCP and clinical data management SOPs
• Experience troubleshooting clinical database and data integrity issue
  
  

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