Sr. Clinical Data Coordinator

Key Responsibilities & Duties:

• Expertise in data management process
• Act as a single point of contact (internal expert) for specific processing task(s) on a project
• Responsible for completeness, timely delivery and quality of clinical data
• Lead and coordinate other team members within the department on assigned studies
• Mentor project team members and be a subject matter expert when needed
• Manage project timelines, quality issues and justify out-of-scope.

• Development of database build specifications
• Development of data validation specifications
• Test data creation & UAT
• Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
• Assist with the validation of edit check programs.
• Data validation and cleaning
• Study status tracking
• Review of data listings
• Conduct SAE & third party data reconciliations
• Maintaining Clinical Study Documents and archiving as appropriate
• Represent Data Management at internal / external meetings as appropriate.
• Perform early and final database QC activities
• Database lock activities

1. A minimum of  5  years in clinical data management 
2. Experience of at least one of ICON preferred CDMS (Rave, Inform, Oracle Clinical, OCRDC)
3. Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project)
4.  Strong client relationship management skills, and the aptitude to develop this further