Senior Clinical Data Manager
TFS HealthScience · Valencia, ES
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. The Senior Clinical Data Manager is part of the Global Biometrics Department within Clinical Development and will work independently on preparing, conducting and completing Clinical Data Management tasks on assigned Study Teams according to company policies, SOP’s and regulatory requirements. Key Responsibilities: Act as Lead Clinical Data Manager for assigned data management projects. Act as a Project Lead for Biometric-only projects. Coordinate work of other Clinical Data Management staff assigned to the project. Review Study Protocol. Develop CRF or review of sponsor-generated CRFs. Develop Database. Define and program edit checks. Responsible to prepare, finalize and archive all related DM documentation. Develop Data Management Plan and Data Management Report. Develop Data Validation Plan (including definition of edit checks. Develop Data Entry Instructions/ eCRF co...