System One Services Clinical Data Manager in Berkeley Heights, New Jersey
Clinical Data ManagerBerkeley Heights, NJ
Category:Scientific & Clinical
Title of Position: Clinical Data Management
Location: Berkeley Heights, NJ
Include, but are not limited to:
Manage CROs and consultants:
Participate in CRO selection
Review SOWs/data management activities and costs in contracts
Interact with CROs in the design and development of CRF's, databases that are compatible with Standards, CDISC and all other company needs pertaining to data management activities
Perform QC of CRO activities to include UAT, Query management, Data review, DM documentation such as DMP, DVS, edit checks, coding, lock process
Monitor progress of data management activities by CROs
Participate in regular team meetings and provide input when appropriate
Ensure inspection readiness by ensuring quality eTMF via QO Reviews
Proficient in writing or reviewing function SOPs/Working Practices
Interact with CRAs, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
Assist in database upgrades/migrations including performing QC of CRO User Acceptance Tests
Must have relevant and Lead experience.
Must be able to work with minimal supervision.
Must be able to communicate well.
Must have experience in managing data management deliverables end to end.
Must be able to work as a W2 contractor - Corp to Corp candidates cannot be considered.
Project driven, not task driven.