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 https://jobs.iqvia.com
