Terms of Reference, Independent Clinical Trial Monitor for Tanzania  

Individual Consultancy assignment. 

Individual Consultancy assignment

“Assessing the acceptability, feasibility, effectiveness and cost-effectiveness of Long-Acting Depot Buprenorphine (LADB) for the treatment of opioid dependence in Low- and Middle-Income Countries” study

Background and context

Médecins du Monde (MdM) is an independent organization of active militants providing care, bearing witness and supporting social change, both in France and internationally. For the past 40 years, we have been committed to working with the most vulnerable individuals and their communities to break down the barriers, preventing them from having access to healthcare. MdM currently works in 30 countries across all continents to facilitate access to healthcare through 6 political battles:

• Sexual and Reproductive Health and Rights
• Migration, Exile, Human Rights and Health
• Harm Reduction
• Environment and Health
• Humanitarian Space
• Healthcare systems and rights

MdM has been present in Tanzania since 2010 and established the first comprehensive harm reduction project for PWUD in Dar es Salaam. In 2019, this project was transferred to the local NGO Mukikute, as a successor to continue providing services, while MdM remained as the technical assistance organization to continue providing technical support for local actors. MdM supported the government of Tanzania to scale up NSP (needle and syringe program) in other regions outside of Dar es Salaam. From 2022 to 2024, MdM supported Ministry of Health and local actors in Burundi to develop OAT guideline and setting up of the very first OAT program in Bujumbura.

Since 2023, MdM, together with the Burnet Institute, INPUD and the University of Bristol engaged in the CUTTS Hep C (Catalyze the Uptake of Underutilized tools for hepatitis C) project, with several research components implemented across 3 countries including Tanzania. This pilot project focuses on the prevention, screening, and treatment of hepatitis C among people who use drugs (PWUD). It aims to improve access to new or under-used prevention tools (long-acting buprenorphine and low dead space syringes), and to implement simplified screening protocols and integrated management models. It is funded by Unitaid and implemented in close collaboration with the WHO.

The study assessing long-acting depot buprenorphine (LADB) for the treatment of opioid dependence is structured as a clinical trial in Tanzania. As such, it requires the involvement of an independent trial monitor.

Scope of work and activities

The Independent Clinical Trial Monitor is a member of the research unit and oversees the planning, execution, and management of the research study, ensuring it complies with regulatory requirements, GCP and ethical standards. The Independent Clinical Trial Monitor collaborates with investigators, regulatory authorities and industry partners to ensure the clinical trial is conducted efficiently and effectively. The role will support data analyses, implement best practices, and contribute to the advancement of medical knowledge and patient care.

• Monitoring Progress: Tracking the progress of the clinical trial against its timeline and target participant recruitment.
• ajiraAdherence to Protocols: Ensuring all research activities are conducted according to established procedures, GCP and ethical guidelines.
• Quality Control: Ensuring data is collected accurately, reported on time, and managed properly in compliance with relevant regulatory frameworks.
• Problem Solving: Reporting gap or misconduct and make recommendations to address any issues or challenges that arise during the clinical trials.
• Reporting: Preparing reports, presentations, and other documentation summarizing findings, progress and challenges.
• Training and Support: Providing guidance and training to research staff and volunteers as relevant and required.

The consultant will work closely with:

• The program manager, program coordinator, country principal investigator and study coordinator for planning monitoring visits to the study sites and ensuring the deliverables are achieved within the timeline
• The international research team of MdM, Burnet Institute, INPUD and University of Bristol to report on the progress regularly

Activities

• Conduct 3 monitoring visits of the study site in Dar es Salaam, Tanzania (Temeke MAT clinic) i.e. baseline, during data collection and endline
• Participate in the briefing and lead the debriefing meetings before and after every monitoring visit with the country and international research teams
• Provide comprehensive monitoring report after every monitoring visit

Outputs / deliverables

• Develop a monitoring report template together with the country and international research teams
• Provide the meeting minutes of each meeting with a clear description on discussion and way forward
• Provide a comprehensive monitoring report, including recommendations, after every monitoring visit

Timeline and working days

From October 2025 to December 2026

3 monitoring visits: baseline, after 6 months and before the end of the project

Qualification and selection criteria

MdM is seeking a consultant with strong experience as research scientist and as a trial monitor for this assignment with the following qualifications, experience and competencies:

• Advanced academic degree (Master or PhD) in the field of health, social science and other health related studies.
• Extensive knowledge and experience in conducting research preferably in clinical trial
• Proven experience of working on similar assignments (as a trial monitor)
• Familiarity and exposure to rights-based approaches to health care
• Ability to work proactively, independently and effectively meeting deadlines
• Excellent command in written and spoken English

Skills required:

• Organizational Skills: Managing tasks, deadlines, and resources effectively.
• Communication Skills: Effective communication with various stakeholders.
• Analytical Skills: Analyzing data, identifying trends, and solving problems.
• Attention to Detail: Ensuring accuracy and compliance with protocols.
• Technical Skills: Strong knowledge and experience in clinical trial

Desirable

• Experience working with Government/Public institutions, international NGOs is highly desirable.
• Experience of working with key vulnerable populations

How to apply

Individual consultants are invited to share the following documents by 5:00 pm East African Time, 7th August, 2025 with hr.tanzania@medecinsdumonde.net with the subject line “Trial Monitor”. Late applications will not be considered. Selection will be on a rolling basis till the position is filled.

• CV
• A cover letter outlining relevant for the assignment
• An example of previous work on a similar assignment (monitoring tools / template, guideline /SoP, training etc.)
• Technical and Financial proposal