Clinical Project Manager

Nairobi, Kenya
[Closing date: 26 November
2019]

 

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, and hepatitis C. 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. 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 2005 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 (esp. Kenya, Uganda, Sudan, Ethiopia, 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 approx. 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 act 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, set-up the kick-off internal meetings and regular trial team meetings
  • Develop on time key documentation (Protocol Synopsis, ICF, protocol, Trial Risk Management Plan, Medical Monitoring Plan, Trial Monitoring plan, Data Management Plan, Statistical Analysis Plan, etc.)
  • Draft the Request for Proposal (RFP) with the procurement representative, for trial specify information
  • Attend the pre-selection or bid-defense meeting, and make the final decision, jointly with their Direct Manager (on the vendor selection)
  • Review contractual documents and ensure that the clinical trial activities are performed according to these documents signed with the vendor and ether possible partners
  • Set-up of the trial specific and electronic Trial Master File (eTMF) at the beginning of the trial and organize the eTMF in accordance with the TMF Table of Content
  • Be accountable and responsible for tracking and reporting the timelines and progress of clinical stud(ies) in the assigned system
  • Ensure the appropriate safety management clinical trial teams as defined in the protocol, monitor plan and medical monitoring plan (if any) in compliance with the trial-specify safety management plan

DSMB: Data Safety Monitoring Board (set-up phase)

  • Evaluate the need or not for a DSMB (with the validation of the Direct Manager and the Medical Director), document the decision, and propose the DSMB chairperson and ether DSMB members
  • Support the Medical Manager to develop the DSMB operating procedure (detailed in the DSMB charter) ensuring proper DSMB development, signature, filing approval as defined in this SOP
  • Ensure 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)

  • Perform the evaluation of the potential site (investigator’s qualifications, trial site staff qualifications, facilities, resources) as per DNDi SOPs and define the requirements that the potential trial site must have for conducting a clinical trial
  • Review and approve the site Pre-Study Visit report and evaluate, 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)

  • Designate an author for the Monitoring Plan, determine content contributors, designate reviewers of the Monitoring Plan, update and approve the Monitoring Plan as required
  • Ensure that the appropriate members (e.g. Monitors) have been trained before the first Monitoring visit occurs.
  • Ensure 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)

  • Forecast the needs for Investigational Products (IPs) in collaboration with Pharmaceutical Development unit, budget purchases, order trial supplies, and ensure that trial supplies are shipped in the appropriate conditions
  • Ensure IP labelling is done according to regulations in the country of the study
  • Ensure 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)

  • Provide support to the Direct Manager with regards to overall trial management and maintain adequate document control for all trial documents
  • Inform proactively the Direct Manager on potential/existing significant non-compliance, delay on timelines, or deviation on current budget
  • Set-up regular meeting within the clinical trial team member and vendors
  • Perform and/or ensure vendors oversight (activities and deliverables) and properly documented for all the clinical activities outsourced
  • Review various reports (Site Initiation Visit report, Site Monitoring Visit Report, documents related to monitoring, site close-out visit report, etc.)
  • Conduct co-monitoring visit during trial conduct
  • Ensure local/regional tracking of compliance (directly or by delegation to Monitors) with local safety reporting requirements
  • Ensuing DSMB procedures are followed, including recommendations distributions and DSMB documentation filing as defined in this SOP
  • Develop and coordinate any protocol amendment and coordinate the implementation of the trial specific documentation
  • File 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
  • Coordinate distribution of IPs, labelling, track the IPs, and ensure resupply and returns as well as destruction, while re-assessing needs an addressing potential quality incidents or complaints arising directly from the site
  • Document any non-implementation of a QD (new/updated QDs for ongoing trials, current QDs for new trials) in the appropriate form
  • Report Major and Critical deviations to the QA unit, perform an Investigation and Root Cause Analysis in case the significance of the deviation is confirmed by QA
  • Develop CAPAs for the deviation, oversee implementation of all CAPAs, and report completion of all CAPA and final close-out in an updated Deviation Report Form

Trial management (reporting phase)

  • Provide clinical trial closure letters by each RAs and ECs, and other bodies (as necessary) to the whole team
  • Organize the Clinical Study Reports (CSR) Kick-Off meeting, coordinate the CSR development process, including its appendices, draft, review, and approve the CSR, and file all the CSR reviews and approvals documentation on in the eTMF
  • Performe 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
  • Compile and review TMF
  • Review, clean, and interpret clinical data

Additional/specific/projects responsibilities

  • Drive clinical trials teams in a matrix environment
  • Achieve database lock of complex clinical trials
  • Coordinate the preparation and compilation of complex Clinical Study Report and appendices
  • Oversee and keep track of submissions of essential documents/reports to local IRBs/HAs and notifying the end of the trial
  • Contribute to the review and writing of publications.
  • Support the Head of Visceral Leishmaniasis team in developing reports to the Scientific Advisory Committee, regular bi-monthly reports, and other documents, as needed.

 

Reporting line

  • S/he reports to the Head of Visceral Leishmaniasis Project
  • Close working relationship with relevant members of the DNDi Africa regional office, Nairobi and DNDi global disease teams

Interactions

  • Work in coordination with visceral leishmaniasis team, based in Geneva, and in the regional offices; as well as with other transversal R&D units (Medical Affairs, Pharmaceutical Development, Translational Sciences)
  • Interact regularly with the partners involved in the programme, service providers/vendors, external stakeholders
  • Member of the Africa regional office Senior Management Team
  • Supervises Visceral Leishmaniasis Project Coordinators and Clinical Research Associates at Africa regional office

 

Job requirements

Skills and attributes

  • Very strong knowledge of drug development
  • Very strong knowledge of clinical research/development
  • Very strong knowledge of regulatory (GCP , GCLP)
  • 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
  • Strategic thinking and leadership abilities
  • Strong management, negotiation, and advocacy skills
  • Have 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

Experience

  • Minimum 6 years’ relevant experience in which at least 4 years at Senior role
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in public and private sector is highly desirable

Education

  • Graduate degree in medical related field
  • Postgraduate/masters degree in relevant field a plus

Other requirements

  • Regional travel up to 50%

 

To apply

  • Deadline for application: Accepting applications until 26 November 2019
  • Only shortlisted candidates will be contacted 
  • Application submission for this position may close early if we have enough suitable applicants