Description
Senior Clinical Data Manager : EDS Medidata RaveThe Senior Clinical Data Manager will lead and coordinate all Data management activities to support all clinical trials. Managing the day to day operations including budgets staff, project scopes, report, internal communication, timelines and communicating the full studies successes and challenges.
As the key POC within the Data Management team you will spearhead CRF designed, Database structure development, annotation, document creation and data entry, also acting as QC for other members of staff to ensure best practice is kept to.
Communication will be essential as you will be expected to communicate cross-functionally and with non technical therapy leads ad CxO level management.
A proven track record of mentoring and getting the best from more junior members of staff is also essential.
Essential experience.
During your 7 - 10+ years of Clinical Data Management experience you should have been fully involved with ICH guidelines, GCP (Good clinical practice and Title 21 of the code of federal regulations.
CFR design, Programming skills in PL/SQL and / SAS accompanied with NDA or PMA submissions and standard libraries is also essential.
EDC knowledge of Medidata Rave is highly desirable as is
To find out more about Real Staffing please visit www.realstaffing.com