Base level role

Perform comprehensive data management tasks including data review, query generation and query resolution.This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc.Data Management tasks should be inclusive of Study Start-up, Execution, Database Lock and Close-out.Perform ongoing Data Reconciliation of all data streamsAttend study related meetings/teleconferencesPerform Study Closeout/Archiving Activities including QC of subject/site Archival CRFsCreate and provide status/metric reportsGenerate reports on EDC and track cleaning progressManage Freeze / lock of eCRFFile documentation in the virtual Trial Master File (TMF)Receives and enters lab normal ranges

Advance level role

Provide timely status updates including issues & risks to DM and DMLs as neededAct as the Point of contact for Clinical Data Manager, working pro-actively to identify risks and provide mitigationsMay communicate with the vendors to resolve reconciliation issues.Provide input to Study set up activities including but not limited to creation of DVRsCreate 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 staffMay serve as an SME and participate in SME forumsMay 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.Data Management experience and experience working on a clinical trial 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 dataProject management skills.Vendor management skills.Proficiency with Microsoft Office toolsExperience CDA BASE level: 1-3 years of experience.Experience CDA ADVANCED level:>3 year of experience

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