The Senior Clinical Data Associate (“CDA”) will have experience in all required areas of a Clinical Data Associate. The Senior CDA is responsible for all data review associated activities for a clinical study. The Senior CDA may assist the Lead with additional data management activities.

Responsibilities:

• Exceed expectations and responsibilities of a Clinical Data Associate
• 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
• Standard Operating Procedures (SOPs)
  • Strong understanding of departmental and company procedures; ability to guide others on procedures

Qualifications: 

• Minimum of 3 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