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 data review associated activities and support to the Lead Data Manager for assigned studies. The Principal CDA will be assigned to complex studies and is expected to coordinate and review the work of other CDAs assigned to their studies as supplemental support.

Responsibilities:

• Follow departmental and company procedures with quality
• Provide input on database design and associated documentation
  
  
  
  1. Review and provide input on draft eCRFs and participate in eCRF screen review meetings
  2. Review and provide input on edit check specifications
  3. Review and provide input on Data Management Plan
  
  
• Author and maintain eCCGs
• Author and maintain study-specific training slides for SIVs
• Conduct user acceptance testing; including, but not limited to, eCRFs, edit checks, database roles, database modules such as RTSM, ePRO, etc.
• Draft database change log and conduct MSU impact assessment
• Draft Data Transfer Specifications
• Write programming specifications for data review, reconciliation, metric report and custom report outputs
  
  
  
  1. Responsible for test data entry and UAT
  
  
• Responsible for data review activities as specified for the study; including coordination of activities for CDAs assigned to the study for supplemental support
  
  
  
  1. DM Review
  2. Discrepancy management
  3. Manual data/data listing review
  4. External vendor reconciliation, maintenance of issue tracker and communicate with vendor regarding issues
  5. SAE reconciliation
  
  
• Run and report on study metrics
  
  
  
  1. Identify and address trends and inconsistencies
  2. Maintain the clean patient tracker
  
  
• Responsible for local lab data handling data entry of reference ranges, quality control and tracking; including coordination of activities for CDAs assigned to the study for supplemental support
• Perform user account management
• Perform data quality control review; including query QC, audit trail and user accounts
• Actively participate in sponsor meetings (depending on time zone)
  
  
  
  1. Take meeting minutes
  2. Facilitate data related discussions
  
  
• Perform EDC archival tasks
• Maintain awareness of the contracted scope of work for assigned studies and communicates status updates to the assigned Lead Data manager as necessary
• Serve as subject matter expert
• Provide training and mentoring for other Clinical Data Associates
• Participate in department initiatives and process improvements
• May participate in the development and revision of department SOPs
• May be expected to perform the duties of the Lead Data Manager role as needed, based on business requirements and competency in the role
• Perform other duties as requested by management

Qualifications:

• Education
  
  
  
  1. Bachelor's Degree preferred, equivalent combination of education and relevant experience may be considered
  
  
• Training
  
  
  
  1. Working knowledge of clinical research best practices preferred
  2. Excellent oral and written communication skills, organizational skills, and attention to detail are required
  
  
• Experience
  
  
  
  1. Minimum of 4 years direct data management experience in pharmaceutical development, CRO, or clinical research environment