Principal Clinical Data Associate

The Principal Clinical Data Associate ("CDA") will have experience in all required areas of a Senior Clinical Data Associate. The Principal CDA is responsible for all data review associated activities for a clinical study. The Principal CDA may provide oversight to other CDAs and may assist the Lead with additional data management activities.

Essential Functions:

• Responsibilities
  
  
  
  • Exceed expectations and responsibilities of a Senior Clinical Data Associate
  • May serve as the Lead Data Manager
  • May assist in the creation of the DMP, eCCGs, Edit Check Specifications, data review listing specifications and other start-up documents
  • Perform user acceptance testing
  • May assist with EDC module integrations/setup (ePRO, Randomization, Dispensing, etc.)
  • Review eCRFs in the database to ensure data consistency and completeness
  • Perform manual data review and data listing review as defined on assigned studies
  • Review and respond to answered queries by the site and issue re-queries as needed
  • Generate manual queries
  • Communicate potential data issues to the appropriate data management personnel
  • Perform reconciliation of SAEs and external vendor data as required for assigned studies
  • Identify data trends and report inconsistencies to applicable data management personnel; collaborate to develop and implement actions to address
  • Perform user account management
  • Collect and report on study metrics
  • Perform data entry or quality control review of local lab data
  • Perform Quality Control review
  • Perform EDC archival tasks
  • Serve as subject matter expert
  • Provide training and mentoring for other Clinical Data Associates
  
  
• Standard Operating Procedures (SOPs)
  
  
  
  • Strong understanding of departmental and company procedures; ability to guide others on procedures
  • Participate in the development and revision of department SOPs
  
  
• Business Development
  
  
  
  • May support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
  
  
• Additional Responsibilities
  
  
  
  • Perform other duties as requested by management
  • Participate in data management candidate interviews
  
  

QUALIFICATIONS:

• Minimum of 7 years direct data management experience in pharmaceutical development or CRO environment
• Bachelor's Degree preferred. Work experience may be substituted for degree
• Working knowledge of CDASH standards
• Excellent oral and written communication skills, organizational skills, and attention to detail are required

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.