Location: Latin América Countries
Objective of the assignment
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 program
Tasks and responsibilities
1st area - 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.
2nd area - 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.
3rd area - 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.
- Clinical study protocols
4th area - 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.
5th area - 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.
6th area - Regulatory, Data Quality and Operational Support
- Coordinate Ethics Committee and Regulatory Authority submissions for assigned projects, ensuring compliance with applicable national regulatory requirements.
- 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.
- 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.
DNDi reference person
- DNDi reference person shall be Head of Cutaneous Leishmaniasis
Consultancy Requirements
Skills and Attributes
- 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.
Experience & Education
- Advanced degree in medicine, health sciences, pharmacy, public health, clinical research, or a related field; MD preferred.
- 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.
Other Requirements
- Based in Latin America
- Fluent in English, with professional proficiency in Spanish and/or Portuguese.
Other information
- Status: Part time – Consultancy