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Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.
DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, hepatitis C, and ANTICOV. Since its inception, DNDi has developed eight new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, and paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.
DNDi Africa was established in 2003 in Nairobi to ensure connection with our founding partner KEMRI and support clinical development programmes. This DNDi regional office conducts R&D projects in the Eastern Africa region (especially Kenya, Uganda, Sudan, Ethiopia, and Tanzania), including clinical activities and data management for clinical trials for treatments for leishmaniasis, paediatric HIV, mycetoma, and others. It also leads capacity strengthening initiatives through multi-country research platforms with the objective to ensure sustainable R&D capacities for DNDi projects. The team has grown to approximately 35 people today. As part of the global strategy, DNDi is further empowering its regional teams to ensure a coherent regional development across disease areas and activities, while reinforcing coherence among disease clusters.
Purpose of the position
The Clinical Project Manager is responsible for overall management of the clinical trial. S/he will play an important role in the development of new drugs and treatments for neglected diseases. S/he acts as a team coordinator for the clinical team trials. S/he will be responsible for the management in the coordination, support, and documentation of the clinical trial phases of the product development, guaranteeing:
- The respect of rights, safety, and protection of the persons participating in the clinical trial.
- The respect of the applicable regulations and recommendations, and of the Clinical Trial Protocol.
- Accuracy, completeness, and consistency of the data collected.
- Implementing the clinical trial according to the agreed timelines, quality and budget.
Specific job responsibilities
Meetings and documentation/contract Management (set-up phase)
- In the set-up phase, sets up the kick-off internal meetings and regular trial team meetings.
- Supports timely development of key documentation (Protocol Synopsis, ICF, protocol, Trial Risk Management Plan, Medical Monitoring Plan, Trial Monitoring plan, Data Management Plan, and Statistical Analysis Plan.
- Drafts the Request for Proposal (RFP) with the Procurement representative, for trial specific information.
- Attends the pre-selection or bid-defense meeting, and makes the final decision, jointly with their Direct Manager (on the vendor selection).
- Reviews contractual documents and ensures that the clinical trial activities are performed according to these documents signed with the vendor and other possible partners.
- Set-up of the trial specific and electronic Trial Master File (eTMF) at the beginning of the trial and organizes the eTMF in accordance with the TMF Table of Content.
- Is accountable and responsible for tracking and reporting the timelines and progress of clinical stud(ies) in the assigned system.
- Ensures the appropriate safety management clinical trial teams as defined in the protocol, monitors plan and medical monitoring plan (if any) in compliance with the trial-specify safety management plan.
DSMB: Data Safety Monitoring Board (set-up phase)
- Evaluates the need for a DSMB (with the validation of the Direct Manager), documents the decision.
- Defines the DSMB operating procedure (detailed in the DSMB charter) ensuring proper DSMB development, signature, filing approval as defined in the SOP.
- Ensures submissions to Ethics Committees (EC)/Institutional Review Boards (IRB) or Regulatory Authorities (RA) of DSMB related information if required as per local regulations (DSMB charter).
Site selection (set-up phase)
- Performs the evaluation of the potential site (investigator’s qualifications, trial site staff qualifications, facilities, resources) as per DNDi SOPs and defines the requirements that the potential trial site must have for conducting a clinical trial.
- Reviews and approves the site Pre-Study Visit report and evaluates, based on the Pre-Study Visit report, the feasibility of running the trial at the site visited and agrees, in collaboration with the Direct Manager on the site selection.
Monitoring (set-up phase)
- Designates an author for the Monitoring Plan, determines content contributors and designates reviewers of the Monitoring Plan and updates and approves the Monitoring Plan as required.
- Ensures that the appropriate members (e.g. Monitors) have been trained before the first Monitoring visit occurs.
- Ensures collaborative support from Data Management, PV, and other functions as required, to develop the trial specify documentation needed for the trial, and inform the Procurement function, when applicable.
Investigational product orders (set-up phase)
- Forecasts the needs for investigational products (IPs) in collaboration with Pharmaceutical Development unit, budgets purchases, orders trial supplies, and ensures that trial supplies are shipped in the appropriate conditions.
- Ensures that trial supplies have been received and stored at site level in the appropriate conditions & stock management and that trial equipment maintenance is done at site level in a timely manner, according to manufacturer recommendations.
Trial management (conduct phase)
- Provides support to the Direct Manager with regards to overall trial management and maintain adequate document control for all trial documents.
- Proactively informs the Direct Manager on potential/existing significant non-compliance, delay on timelines, or deviation on current budget.
- Sets up regular meeting within the clinical Trial team member and vendors.
- Performs and/or ensures vendors oversight (activities and deliverables) and properly documented for all the clinical activities outsourced.
- Reviews various reports (Site Initiation Visit report, Site Monitoring Visit Report, documents related to monitoring, site close-out visit report etc.).
- Conducts co-monitoring visit during trial conduct.
- Ensures local/regional tracking of compliance (directly or by delegation to Monitors) with local safety reporting requirements.
- Ensures ensuing DSMB procedures are followed, including recommendations distributions and DSMB documentation filing as defined in this SOP.
- Develops and coordinates any protocol amendment and coordinates the implementation of the trial specific documentation.
- Files the trial specific documentation in the eTMF and ensures that the Trial Deviation Log is properly maintained and up-to-date, and reviews the eTMF completeness on a regular basis.
- Coordinates distribution of IPs, labelling, tracks the IPs, and ensures resupply and returns as well as destruction, while re-assessing needs an addressing potential quality incidents or complaints arising directly from the site.
- Documents any non-implementation of a QD (new/updated QDs for ongoing trials, current QDs for new trials) in the appropriate form.
- Reports Major and Critical deviations to the QA unit, performs an Investigation and Root Cause Analysis in case the significance of the deviation is confirmed by QA.
- Develops CAPAs for the deviation, oversees implementation of all CAPAs, and reports completion of all CAPA and final close-out in an updated Deviation Report Form.
Trial management (reporting phase)
- Provides clinical trial closure letters by each RAs and ECs, and other bodies (as necessary) to the whole team.
- Organizes the Clinical Study Reports (CSR) Kick-Off meeting, coordinates the CSR development process, including its appendices, drafts, reviews and approves the CSR, and files all the CSR reviews and approvals documentation on in the eTMF.
- Performing a full reconciliation with any external stakeholders (vendors/consultants, etc…) prior to archiving.
- Archiving of the eTMF following closure of a trial and submission of the final trial report.
- Driving clinical trials teams in a matrix environment.
- Achieving database lock of complex clinical trials.
- Coordinating the preparation and compilation of complex Clinical Study Report and appendices.
- Overseeing and keeping track of submissions of essential documents/reports to local IRBs/HAs and notifying the end of the trial.
- Contributing to the review and writing of publications.
- S/He reports to the Senior Clinical Project Manager
- Close working relationship with the Head of Regional Clinical Operations, relevant members of the DNDi African regional office, Nairobi and DNDi global disease teams.
- Supervises Mycetoma and ANTICOV Project Coordinators and Clinical Research Associates at the African regional office.
- Minimum 6 years’ relevant experience in which at least 4 years at Senior Officer level.
- Proven ability to work effectively in a team environment and matrix structure.
- Experience of working in public and private sector is highly desirable.
Skills and attributes
- Very strong knowledge of drug discovery/development
- Very strong knowledge of clinical research/development
- Very strong knowledge of regulatory (GCP, GLP, and GMP)
- Very strong knowledge of disease/academia knowledge
- Very strong technical writing skills (procedures, protocols, and reports)
- Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
- Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
- Strong communication skills in multicultural, multi-lingual environments
- Strong ability to work effectively as part of a multicultural team
- Well organized and structured
- Strong analytical skills
- Strong ability to provide high level support in project/programme delivery
- Strong ability to manage medium/large projects with budget management
- Strategic thinking and leadership abilities
- Strong management, negotiation, and advocacy skills
- Has autonomy for taking actions and decisions
- Strong ability to interact with external stakeholders
- Lead and motivate a small team for optimum performance, supervising junior staff
- Medical degree (MBChB) graduate.
- Postgraduate/masters degree in relevant field a plus
- Travel up to 50%
- Please submit your application using the online form
- Deadline for application: Accepting applications until 18 April 2021
- Only shortlisted candidates will be contacted
- Application submission for this position may close early if we have enough suitable applicants