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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Clinical Database Designer

Job ID 81578BR Germany, Remote

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.
This is an office-based role in Berlin.

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 ClinBase ™ as it relates to specific protocol needs.
  • Provide any necessary ClinBase™ output files/reports for sponsor review as applicable. 
  • Generate procedure orders as needed. 
  • Proactively plan study setups are ready and released for scheduled trial subject visits.
  • 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 ClinBase ™ Support and the Development Group to existing or creation of new ClinBase ™ modules 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. 

Skills, Knowledge and Experience: 
  • 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.
  • 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.

Language skills

  • Fluent in English, oral and written
  • Fluent in local language, as applicable

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