Responsibilities
POC for project teams, company departments, and clients for any Data Management queries
Oversee/liaise with all external vendors
Responsible for DM activities within projects including:
Coordinate DM activities within clinical projects
Study document reviews
DMP and other project-specific guidelines and instructions development and review
Developmnt of data validation plans
Data validation
Non-CROF electronic data handling (receiving, archiving, loading into database, review and resolution of reconscilliation issues, feedback to vendors)
Manual CRF review
Clinical database lock
Input into design of CRFs and review Case Report Forms
Train junior Data Managers
Mentor junior Data Managers
Project specific training
Prepare and represent the team in internal and external meetings
Requirements
MSc/PhD within life sciences / statistics / something relevant
5+ years’ experience within the Life Science industry (CRO/Pharma/Biotech)
Experience with CDM systems (Rave, Oracle, Inform, ClinTrial)
CDISC knowledge
Experience leading studies (ph I-IV)
Experience mentoring/training others
Oxford
