The main task of the eCRF (Electronic Case Report Form) Validation Expert is to perform all necessary activities related to the creation of the EDC DVR specifications and validation documents and follow-
up on User Acceptance Testing.
Assist the (e-)CRF Designers on the eCRF screens and / or Screen Review Meeting
Review functional specifications for ePRO-tools
Generate and maintain functional specifications for the EDC tool Data Validation Rules.
Liaise with the Team Managers Data Management / Data Management Assistant Coordinator on resource allocation for User Acceptance Testing (UAT)
Create test steps and validation documents for User Acceptance Testing of eCRF and ePRO tools
Coordinate User Acceptance Testing
Generate and maintain training documentation for the eDC end-users
Perform tasks that are typically assigned to other (Sr) EVALEs to allow flexible resourcing in case of high workload for specific EVALE activities
Complete and file appropriate standard forms and documents
Ensure all trial and sponsor related applicable trainings are followed and training is documented in the study file and / or sponsor specific binder
Keep open and constructive contacts with all involved internal Benelux departments
Intensive communication with sponsor contact
Intensive communication with the Project Manager Biometrics (PM Biom)
Intensive communication with internal eSolutions / Data Management contacts who are responsible for the trial
Distribute relevant information about the eCRF Validation Expert tasks related issues / processes / procedures / problems to the other (Sr) EVALEs and entire (e-
CRF group, when applicable
In case of an (internal) audit on a project for which the eCRF Validation Expert activities were performed by EDC sub-
department, provide clear and well motivated responses to the auditors for the executed study tasks.
Scientific master degree
Fluency in English and Dutch
Specific requirements and / or competences : Flexibility, confidentiality, respecting timelines, being accurate and have an eye for detail, affinity with complex PC programs, quality minded, communicative skills, positive, constructive, professional attitude towards colleagues and sponsors, Problem-
solving minded, pro-active, time management skills, stress resistance.
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