Clinical Data Associate – Advance needed at IQVIA

Advance level role

• Provide timely status updates including issues & risks to DM and DMLs as needed
• Act as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigations
• May communicate with the vendors to resolve reconciliation issues.
• Provide input to Study set up activities including but not limited to creation of DVRs
• Create and/or provide inputs to Data Management documents (e.g. eCRF completion guidelines, etc.).
• Review and provide inputs to Data Management documents (e.g. IRP, DMP, etc.)
• Assign work to allocated CDAs on a trial. Coordinate work of CDAs assigned to a study working closely with the Global Data Manager to understand priorities and timelines.
• Assist the Data Management Leader in TMF compliance reviews.
• Train and mentor CDA staff
• May serve as an SME and participate in SME forums
• May act as delegate for Data Manager, as needed

Education and Experience Guidelines:

• Bachelor’s degree in a Health or Science discipline with experience in clinical research.
• Experience CDA ADVANCED level: >3 year of experience Data Management experience
• Data Management experience and experience working on a clinical trial mandatory.
• Rave experience mandatory
• Experience working in highly diverse teams within clinical research; cross-functional, global, multi- regional.
• Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) for Advanced CDA.
• Knowledge of technology platforms and systems to capture and process data
• Project management skills.
• Vendor management skills.
• Proficiency with Microsoft Office tools