Clinical Trial Project Management Consultant

The Research and Development Department includes two clusters of disease expert teams NTD Parasitic Diseases and Viral/Fungal Diseases. Integrated Clinical Development Sciences (Drug Safety & Pharmacovigilance, Clinical Quality Assurance, and Translational Sciences), Regulatory Sciences, Clinical Operations, Discovery, and Pharmaceutical Development teams complement DNDi’s R&D expertise. The department drives therapeutic innovation from the lab bench to the patient bedside, advancing DNDi’s portfolio of treatment candidates from the outset (with the design of target product profiles) to the end point (enabling patients’ access to new treatments).”

DNDi established its Latin American office in Rio de Janeiro in 2004. Since then, DNDi Latin America has made extensive contributions to advancing R&D and access partnerships across the region’s diverse health ecosystems. Its work spanning neglected diseases such as Chagas disease, leishmaniasis, hepatitis C, and dengue plays a central role in delivering DNDi’s global strategy. The office also leads advocacy efforts and drives capacity-building initiatives through multi-country clinical research and drug discovery platforms.

The Consultant will provide specialized clinical project management services in support of specifically assigned Phase II/III clinical trial activities within the CL program, with responsibility for the agreed deliverables described in this ToR and autonomy regarding the organization and execution of the services.

Working across multidisciplinary teams, the Project Manager will take ownership of assigned activities, proactively manage risks and timelines, and facilitate collaboration among internal functions, CROs, investigators, and external partners. The individual will also support the Head of Disease in selected scientific and programmatic activities, ensuring alignment with the overall priorities of the CL program2.

The Consultant will hold the following responsibilities and accomplish the following tasks

Clinical trial planning and coordination

• Provide specialized project management services related to the planning, implementation and follow-up of the Phase II/III clinical trials specifically assigned under this consultancy, including the preparation and maintenance of agreed project management deliverables. Monitor trial progress against milestones and proactively identify potential delays or risks.
• Develop and maintain study timelines, project plans, trackers, and key deliverables to ensure timely follow-up and escalation where appropriate.
• Ensure trial activities comply with ICH-GCP and relevant regional and international regulatory requirements, including EMA/FDA requirements.
• Support study governance and contribute to effective project execution.

Cross-functional project management

• Provide specialized technical input and coordinate activities with relevant DNDi functions and external partners in relation to the specific clinical trial deliverables covered by this assignment, without exercising line-management or hierarchical authority over DNDi personnel. Facilitate alignment of study objectives, timelines, deliverables, and dependencies across teams.
• Organize project team meetings, governance meetings, and study-related workshops, including agendas, minutes, and follow-up actions.

Study documentation

• Lead the development and maintenance of key clinical study documents, including, but not limited to
• Clinical study protocols
• Informed consent forms
• Monitoring plans
• Manuals of operations
• Risk management plans
• Clinical study reports.

Vendor, CRO coordination

• Provide technical and project coordination services in relation to CROs, vendors and external service providers involved in the assigned clinical studies, monitoring agreed deliverables and milestones and reporting relevant issues to the designated DNDi technical focal point.
• Track external deliverables and support issue resolution in collaboration with relevant functional leads and/or team members.
• Coordinate activities with relevant internal and external stakeholders involved in trial delivery.
• Provide oversight and coordinate tasks related to clinical trial supplies within the scope of the assigned studies, including identification and reporting of potential supply-related risks or issues Provide training during Site Initiation Visits (SIVs) and investigator meetings.

External partner engagement

• Provide specialized technical and scientific support for engagement activities with Ministries of Health (MoH), the Pan American Health Organization (PAHO), academic institutions, and other relevant stakeholders, specifically in relation to the clinical research activities and deliverables defined under this consultancy.
• Promotes the Leishmaniasis Network (RedeLEISH) development in the region, in coordination with Head of the Disease and RedeLEISH Coordinator.

Regulatory and ethics coordination

• Coordinate Ethics Committee and Regulatory Authority submissions for assigned projects, ensuring compliance with applicable national regulatory requirements.

Data management and quality

• Liaise with the data management team on eCRF design and database set-up.
• Contribute to clinical data review to ensure consistency and quality.
• Coordinate database locks and the release of data tables, listings and figures.

Financial and operational support

• Provide financial tracking and analytical support for the assigned clinical trial activities, including preparation of budget monitoring information and identification of potential deviations for consideration by the relevant DNDi budget holder.

Reporting and communication

• Provide technical coordination and information-sharing support among relevant DNDi teams, CROs, investigators, study sites, and external collaborators, as needed to facilitate the delivery of the specific clinical trial activities and deliverables covered by this consultancy
• Prepare study status reports, dashboards, presentations, and trial updates. This may include presenting clinical trial results at scientific conferences.
• Contribute to Scientific Advisory Committee reports, Action Plans, grant proposals and donor reports.
• Contribute to the preparation of program updates and dissemination, including writing and review of scientific publications.
• DNDi reference person shall be Cutaneous Leishmaniasis
• Advanced degree in medicine, health sciences, pharmacy, public health, clinical research, or a related field; MD preferred.
• Based in Latin America
• Fluent in English, with professional proficiency in Spanish and/or Portuguese.
• 5-7+ years of experience in clinical research, clinical operations, project management, medical affairs, or related functions within pharmaceutical, biotechnology, CRO, academic, or global health organizations.
• Desirable Experience
• Experience as a Medical Monitor or Clinical Research Physician.
• Experience working with CROs, investigators, and study sites.
• Experience supporting Phase II-III clinical studies.
• Experience supporting multinational clinical studies, particularly in Latin America.
• Experience in infectious diseases, tropical diseases or neglected tropical diseases is desirable.
• Existing network within infectious diseases, tropical medicine, or leishmaniasis research communities is an asset.
• Strong planning, organization, and execution skills
• Ability to manage multiple priorities and competing timelines.
• Proactive risk identification and problem-solving.
• Strong attention to detail and follow-through.
• Excellent written and verbal communication skills.
• Ability to communicate effectively with scientific, clinical, operational, and external stakeholders in multicultural environments.
• Strong facilitation and stakeholder management skills.
• Ability to work effectively within matrix teams and across geographies.
• Fluent in English, with professional proficiency in Spanish and/or Portuguese.
• Good knowledge of Microsoft Suite

DNDi is committed to building a diverse, equitable and truly inclusive organisation. Our success and global reach are dependent upon our ability to encourage diversity and draw on the skills, understanding and experience of all our people. We particularly welcome applications from those who are underrepresented in at DNDi and across the sector, especially women, and including, but not limited to, black and minority ethnic candidates, and those with other protected characteristic.