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Clinical Database Designer
vor 2 Wochen
The Clinical Database Designer creates ‘study setups’ (i.e. the composition of study procedures for clinical data capture from pre-defined procedures in the procedure catalogue) in the clinical trial management system ClinBase according to protocol requirements and internal (including PAREXEL-wide) standards in close cooperation with the Clinical Operations, Data Management and Bio Statistician departments. These study-specific setups provide the basis for electronic source data capturing.
The Clinical Database Designer provides technical expertise regarding setup definitions and gives guidance during the setup review process to the study team.
- Participate in the review process of the clinical study protocol, protocol amendments and other study related documents as applicable.
- Create, initiate and maintain timelines related to the ClinBase set-up for a specific study.
- Ensure that the set-up reflects protocol and other data specification requirements.
- Work with and support study team members during the set-up, review, and release phases of ClinBaseas it relates to specific protocol needs.
- Provide any necessary ClinBase output files/reports for sponsor review as applicable.
- Generate procedure orders as needed.
- Implement any changes if/when require due to amendment, Safety Review Meeting outcomes and/or team requests.
- Maintain setup documents and perform quality control checks to ensure accuracy completeness.
- Provide and assist project teams with report printing for projects where applicable.
- Maintain database for optimum performance (including Procedure Catalogue).
- Maintain ClinBase Procedure Catalogue and Partnership study folders and update as required.
- Provide input into ClinBaseSupport and the Development Group to existing or creation of new ClinBasemodules to better meet the needs of the unit and Sponsors.
- Work with colleagues in the other PAREXEL Early Phase Units in the exchange of knowledge and harmonization of ClinBase processes.
- Participate in SOP development (including respective forms and templates) and revisions.
**Qualifications**:
- Strong organizational, analytical and verbal and written communication skills.
- Excellent communication skills and good written and spoken English and German
- Ability to prioritize different process requirements in parallel across same and different studies/projects
- Ability to maintain good quality, keep oversight, meet deliverables under time pressure. Ability to work independently
- Advanced level of computer literacy (e.g. Windows Office suite)
- Strong sense of ownership and accountability.
**Knowledge and Experience**:
- Intermediate experience of working in a multi-disciplinary team
- Intermediate experience in supporting counterparts and peers
- Understanding of Electronic Data capture and other eCRF systems
**Education**:
- Bachelor of Science/Master of Science in a health related, science or equivalent experience in any clinical health care occupation.
