Sr. Clinical Data Manager
CurrentSetting up a clinical study from start till end (biometrics):• Serve as primary contact for all data management activities• Keeping in-depth oversight of all study related activities• Fine-tuning the SDTM structure of datasets (CDISC compliant)• Defining the cleaning package to review the case report form (Medidata Rave)• Detecting and reporting of protocol deviations• Coding of medications and medical events• Writing, reviewing and validating trial related documents and data transfer agreements with external parties• Perform User Acceptance Testing (UAT) of the EDC Tool• Ensure that all DM related documents are complete and timely filed in (e)TMFTherapeutic areas:• Early development oncology• Respiratory systemSide activity: organising team events