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