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Clinical Database Designer

Employer
Parexel
Location
Germany
Salary
Competitive
Start date
9 Dec 2022
Closing date
8 Jan 2023

View more

Discipline
Data Management / Statistics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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