FierceBiotech and FiercePharma Jobs
Clinical Data Manager - Global Allied Pharmaceuticals
Jan 12
Location: Various Locations, Categories: Pharmaceutical
Website: http://www.gapsos.com
Position Description
Responsible for managing data management activities, liaising with CRO’s and interfacing with Clinical Operations on behalf of the Data Management Department to ensure that standards are communicated properly, that timelines are met according to objectives and goals and that data reporting needs are scheduled and addressed and that the quality of data management deliverables are monitored. Review CRF design. Create CRF Completion Guidelines/Mock CRF’s and coordinate their review and approval Review and approve Data Management Plan components, i.e., study summary/data flow diagrams, timelines, critical variables list, etc. Review Data Validation Specifications and coordinate input for Biometrics/Data Management Departments to ensure that Statistical Analysis Plan (SAP) requirements will be met Specify data review tools to be included in CRO’s data validation process to ensure that safety and SAP requirements are met Represent department on clinical trial team, project management and status reporting Handle AE/SAE reconciliation Bachelor’s Degree in Life Sciences, Pharmacy or Nursing with 5 or more years of experience in drug development and the discipline of data management or an equivalent combination of training and experience. Experience in Oracle Clinical data management system and familiarity with SAS required.
