IT Digital Study Lead

Job Title: IT Digital Study Lead

Location: Brussels , NL

Employment Type: 

Contract

We are looking for an IT Digital Study Lead to manage the implementation and oversight of digital solutions in clinical trials. This role emphasizes the integration and configuration of clinical outcomes assessment tools, focusing on patient and physician-reported outcomes.

Responsibilities:

• Understand Study Requirements: Identify and translate study-specific requirements (software, devices, etc.) into configurations aligned with product capabilities.
• Deliver Technology Products: Ensure successful delivery of technology products within the clinical studies technology suite.
• Project Management: Oversee study implementation, manage project planning, and interpret study protocols to integrate with digital solutions.
• Support and Configuration: Develop study configurations, provide second-level support, and offer "how to use" guidance to study sites.
• IRB/EC Submissions: Package patient content for IRB/EC submissions and ensure proper eCOA translations and validations.
• Stakeholder Engagement: Collaborate with key stakeholders to gain support and ensure compliance with regulations and IT governance rules.

Criteria:

• Understanding of clinical operations across all phases.
• Experience in setting up and implementing clinical studies.
• Experience with digital solutions (eConsent, patient-reported outcomes, clinician-reported outcomes, eDiaries, and related processes).
• User Acceptance Testing experience in clinical studies.
• Project management experience.
• Experience with Veeva (preferred).

This role is critical for ensuring the successful implementation and support of digital solutions in clinical trials. If you have the required skills and experience, we encourage you to apply.

To apply for the IT Digital Study Lead position located in Brussels, please send your resume to [email protected]. Be sure to include the name of the position and location in the subject line of your email. We look forward to reviewing your application and exploring the possibility of you joining our dynamic team at Halian.

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