Description
Senior Clinical Data Manager : EDC, Medidata RaveA growing Oncology Biopharma situated in the Cambridge area is in search of a Senior Clinical Data with EDC experience across Medidata Rave.
As one of the keep people in the clinical data management and Biometrics team you will be managing all aspects of the clinical Data management process from study start ups to database locks or Electronic Data Capture (EDC) for all in-house trials.
Accompanied with being the internal go-to for clinical data management vendor & CRO management will be key, ensuring that timelines and technical project best practice is adhered to.
Qualifications needed:
4+ years Clinical Data Management experience working with in the pharma/biotech or medical device industry, experience with EDC, Medidata Rave is essential as is SDTM and C-DASH, . Understanding of ICH and the regulations relating to clinical data management.
Overall responsibilities
Work as part of the Clinical study teams
Liaise with CROs and EDC vendors o ensure deliverables are met
Working with database builders to develop EDC Databases and revisions
Develop specifications for UAT requirements
Specify Electronic and Manual checks
Create and revise clinical data management documentation
Identify and trouble shoot operational and technical problems
Coordinate Pharmacovigilance on adverse event reconciliation
Provide leadership for cross-functional teams.
To find out more about Real please visit www.realstaffing.com