Description
We are seeking an Advanced Clinical Data Manager to join our team. As an Advanced Clinical Data Manager, you will provide timely status updates, including issues and risks, to the Data Manager and Data Management Leads as needed.
Key responsibilities:
- Act as the point of contact for Clinical Data Managers, working proactively to identify risks and provide mitigations
- Communicate with vendors to resolve reconciliation issues
- Provide input to study setup activities, including creation of Data Verification Reports (DVRs)
- Create and provide inputs to Data Management documents, such as eCRF completion guidelines
- Review and provide inputs to Data Management documents, including IRP and DMP
- Assign work to allocated Clinical Data Associates (CDAs) on a trial and coordinate their work with the Global Data Manager
- Assist the Data Management Leader in TMF compliance reviews
- Train and mentor CDA staff
- May serve as a Subject Matter Expert (SME) and participate in SME forums
- May act as a delegate for the Data Manager as needed
Requirements:
- Bachelor's degree in a Health or Science discipline with experience in clinical research
- Advanced level experience in Data Management, with over 3 years of experience
- Experience working on clinical trials and using Rave is mandatory
- Knowledge of current industry standards, such as CDISC, SDTM, and CDASH
- Project management and vendor management skills
- Proficiency with Microsoft Office tools