Clinical Data Manager
TFS HealthScience · Lisbon, PT
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout...
Job description
About this role TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. Clinical Data Manager is part of the Global Biometrics Department within Clinical Development and will work operationally on preparing, conducting and completing Clinical Data Management tasks on assigned Study Teams, according to company policies, SOPs and regulatory requirements. Key Responsibilities: May act as a Lead Clinical Data Manager. Coordinate work of other Clinical Data Management staff assigned to the project. Provide guidance for Data Entry and Data Associates. Review Study Protocol. Develop CRF or review of sponsor-generated CRFs. Develop Database. Responsible to prepare, finalize and archive all related DM documentation. Define and program edit checks. Develop CRF completion guidelines. Coordinate validation of database, edit checks and trial and site settings. May perform validation of database, edit checks and trial and site settings in studies where n...