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
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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What We Do
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.
