Clinical Data Manager
As an Imaging CRO, Perspectum provides Data Management Services for clinical trials.
The Clinical Data Manager for the imaging CRO Business Unit will support the Imaging CRO Service by developing a database for effective management of trial data. This database will provide analytics on all aspects of the Clinical Trial data, working with the Business Development, Clinical Project Management and Services and Analytics Team. The Data Manager will develop and implement effective and compliant data management processes.
- Work with Clinical PJMs to build a patient tracking system with automated alerts
- Work with Pharma Analytics and Service Manager to create imaging endpoint databases, configured per sponsor/main CRO requirements to facilitate a delivery of weekly/monthly analytics, data quality metrics and recruitment metrics
- Design eCRF, Data Management and Data Validation Plans and test databases
- Track database set-up, testing, maintenance and data entry
- Manage integration of third-party data into databases
- Write Data Transfer Agreements; Liaise with sponsor/main CRO and Pharma Analytics and Service Manager on technical requirements
- Manage all data transfers to/from third parties (Sponsor, main CRO, SMO, etc)
- Continually Monitor and Report progress in study programmes
- Perform Data Reconciliation at end of study and interim reviews
- Close out studies; Archive Study Data when appropriate
- Archive Ancillary Data (imaging data not considered to be Study Data)
- Work with QAS Data Manager(s)
- Act as major stakeholder in the development of a quantitative results database.
- Liaise with QA and Privacy Officer to ensure compliance with GCP
Skills and Requirements: Essential
- Degree or higher graduate degree in a science related field
- Knowledge of effective clinical data management practices
- GCP Trained
- A minimum of one year's experience with CDM systems
- Experience working in the technology sector
- An ability to problem solve over a complex range of tasks subject to competing contractual, financial, personnel and time constraints
- Organizational skills and the ability to rapidly prioritize tasks in response to unexpected opportunities or risks
- Communication skills, both oral and written; The ability to use these skills in a customer facing role
- Ability work effectively with other teams internally
Skills and Requirements: Desirable
- Contract Research Organization (CRO) experience
- Experience with Jira workflow manager
- Experience in CRMs
Interested in this position?
We are always looking for brilliant people to join us here at Perspectum Diagnostics.
Use the form below to send us your application.