Clinical Data Manager
The Clinical Data Manager is responsible for the setup and maintenance of the Clinical Data Management system and for the collection, review and validation of the clinical data in a timely manner to ensure adequacy, integrity and quality of the data.
Duties and Responsibilities
- Track database set-up, testing, maintenance and data entry
- Manage integration of third-party data into databases
- Review and assure the quality, accuracy and completeness of production data transfers
- Identify, investigate and reconcile data discrepancies
- Continually Monitor and Report progress in study programmes
- Conduct database lock, study closeout and reconciliation activities
- Conduct applicable data analysis activities
- Assist with creation and maintenance of data transfer specifications
- Assist with development and versioning of CDM department SOPs
- Perform other tasks as needed
- Write data validation plans and data management plans
- Write Data Transfer Agreements, liaising with Project Managers and/or CRO
Skills and Knowledge: Required
- Educated to first degree level in a science-related subject
- Experience with Clinical Data Management system(s)
- Overall understanding of ICH, GCP, CDISC, 21 CFR Part 11 and other applicable regulatory guidelines
- An ability to problem solve over a complex range of tasks subject to competing contractual, financial, personnel and time constraints
- Organisational skills and the ability to rapidly prioritise tasks in response to unexpected opportunities or risks
- Ability to work independently and as part of a team
- Excellent written and oral communication skills
Skills and Knowledge: Desired
- Educated to higher degree level in a science-related subject
- Experience in EDC systems builds and core configuration
- Knowledge of effective clinical data management practices
- Knowledge of The Good Clinical Data Management Practices (GCDMP) and Food and Drug Administration (FDA) medical device regulations and guidelines
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.