Trial Data Manager

Job title : Trial Data Manager
Location : Switzerland
Salary : €600 - €650 per day
Contact name : Nitin Wadhwani
Contact email : Nitin.wadhwani@secrecruitment.com
Our leading International client are looking for an experienced Trial Data Manager to join them on an initial 1 year contract basis from their offices near Basel in Switzerland

The role:
*Ensures that Data Management (Biometry) activities (related to assigned study) adhere to Client Standards, and applicable regulations
*Meets study timelines in terms of Data Management deliverables
*Ensures data handling consistency within allocated study(ies)
*Leads Data Management activities for assigned study
*Provides Data Management input to the development of the study protocol
*Coordinates the development of the (e)CRF in line with Client standards
*Writes all study Data Management documents covering specifications for external data transfer, data cleanings and review tools that will be further provided to Data Management Programmer(s) for development for the allocated study(ies)
*Organizes, monitors and tracks the testing of data entry screens (eCRF layout), data cleaning / review tools, and their implementation in the production environment
*Organizes, monitors and tracks data cleaning, data review, query management, and database lock. Makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders
*Generates study metrics and status reports
*Represents Data Management at Clinical Trial Team (CTT) meetings
*Manages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing/outsourcing partners' management)
*Prepares and archives Data Management study documentation


Experience / Skills required:
*Recognized degree in life sciences, mathematics, statistics, informatics or related disciplines
*At least 3 years' experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical
*Data Management with good level of functional expertise in Data Management
*Good knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization - Good Clinical Practice (ICH/GCP))
*Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) design
*Ability to lead and coordinate the activity of Data Manager(s) allocated to his/her study
*Fluent in written and spoken English
*
For further information please contact Nitin on +44 (0)207 255 6655 or +41 (0)44 580 3717 or via email at nitinw@secrecruitment.com