Study Data Manager

United Kingdom, England, Welwyn Garden City, Hertfordshire

Roche have exciting opportunities available to join Pharma Development Clinical Data Management in the Early Stage Development group in Welwyn Garden City, UK.

The Study Data Manager (SDM) is a core member of the Study Management Team (SMT).  In this role the SDM represents all Clinical Data Management functions on a clinical study level. The SDM is responsible and accountable for the leadership, planning, co-ordination and timely delivery of a high quality database to enable data extraction and analysis for one or more clinical studies.

Clinical studies may be run in different sourcing models, and may involve the oversight of external business partners delivering parts of, or all of the clinical data management activities of a study. Where activities are outsourced to an external business partner, the SDM maintains the sponsor accountability for delivery.

During study set-up you will lead or maintain oversight of the electronic case report form (eCRF) design to ensure timely delivery to the investigative site for study start.

During the study you will be responsible for coordinating, performing or maintaining oversight of the review of study data, discrepancy management and data cleaning in conjunction with Science, Medical Coding, and Data Acquisition to ensure the high quality clinical data extraction for data analysis.

During study close you will perform or maintain oversight of freeze and locking and/or planned unlocking of study databases according to requirements of the SMT.

Your non-study responsibilities will include actively supporting the function to optimise functional processes, support colleagues and drive the functional strategy.