The Data Manager will be responsible for data management activities in small or medium sized projects under direct supervision, or in a supportive data management role in large, complex studies.
Communication
– Secondary or back-up communication point for project teams and company departments with regard to clinical data management
– Secondary or back-up communication point for clients for clinical data management aspects of clinical projects and data management reporting
Data Manager
– Tracking database set-up, testing, maintenance and data entry
– Shared responsibility for clinical data management activities within clinical projects
– Input into design of CRFs and other data collection forms; review case report form design for accuracy and adherence to protocol
– Development of CRF completion guidelines
– Coding medical data with coding dictionaries and cording listings review (DMs with medical/biology background, additional training required)
– SAE reconciliation
Document Management
– Liaise with Document Center with regard to maintenance of PMF and ePMF (CRFs/queries/study documents)
Quality Control
– Database QC checks
– Shared responsibility for attending internal and client/third-party audits/inspections of Data Management
Training
– Training of Assistant Data Managers
– Project-specific training of investigators and clinical team in CRF completion
Corporate/Departmental Assignments
– Investigator Meetings preparation/attendance
– Meetings and teleconferences organized by client preparation/attendance
PSI is a leading full-service global Contract Research Organization. Predictable patient enrollment across multiple therapeutic areas.
