Consultant for Digital Needs Assessment and Technical Specification Development for Rwanda’s Ethics and Regulatory Systems
 

Background

As part of the TRACE Project (Clinical Trials Regulatory and Ethics Systems Optimization Project), CIIC-HIN, with support from the Gates Foundation, is leading Rwanda’s effort to strengthen its clinical trial ethics and regulatory system. One key intervention is the digital transformation of the ethics and regulatory workflows. This assignment seeks to assess the current digital landscape (RHInnO Ethics, IRIMS, and IRB processes), identify gaps, and define functional and technical requirements for a harmonized, efficient digital platform.

Objective of the Consultancy

To conduct a digital needs assessment of RNEC, Rwanda FDA, and IRBs, and define user-driven technical specifications to inform platform enhancement and interoperability.

Scope of Work

The consultant will be responsible for the following tasks:

• Review current platforms (RHInnO Ethics, IRIMS) and IRB digital practices.
• Conduct functionality assessment and identify gaps.
• Collect user feedback from ethics committee members, administrators, and applicants.
• Assess system interoperability across RNEC, Rwanda FDA, and IRBs.
• Propose user requirements and functional specifications to guide digital enhancements.
• Recommend system upgrade options, data hosting, security (per Rwanda DPP law), and change management processes.

Deliverables

• Inception report with methodology and tools
• Digital gap analysis report
• User requirements specification document (detailing functionality gaps, user feedback, interoperability needs)
• Final technical specifications and recommendation report with cost implications.

Duration and Timeline

The consultancy will be conducted over 15 working days between July and August 2025. A detailed schedule will be agreed upon during the inception phase.

Qualifications and Experience

• Advanced degree in IT, Health Informatics, or related field
• Minimum 5 years of experience in digital health assessments
• Experience with ethics/regulatory systems in LMICs
• Strong stakeholder engagement and facilitation skills
• Familiarity with Rwanda’s health system and digital governance preferred

Reporting

The Consultant will report to the CIIC-HIN Rwanda Project Lead and the Digital Transformation Technical Working Group (TWG). Weekly check-ins and milestone-based reporting will be expected.

How to apply:

Interested candidates should scan and compile all application documents into a single file and submit the following:

• A cover letter outlining relevant experience and motivation.
• A detailed CV with at least three professional references.
• Copies of academic certificates.

Subject line: Application – TRACE Consultant SOP Review

If you believe you meet the above requirements and wish to view a more detailed job description and wish to apply,

visit this link: https://ciichin.org/digital-consultant/

The application deadline is Friday, 18^th July 2025.

Incomplete files or late applications will not be considered.

Only shortlisted candidates will be contacted.