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:
Bachelors 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
Required Experience:
IC
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more