Clinical Trial Manager (CTM) – Mycetoma & GARDP

Nairobi, Kenya
[Closing date: October 13, 2017]
                                                                 

 

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 seven 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 programs. 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. 30 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.

In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research and Development Partnership (GARDP), a not-for-profit research and development initiative to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all. GARDP aims to have at least two projects that address urgent global health needs ready for implementation by the end of 2016, and two more by the end of 2017.

In this context of increasing activities and regionalization, DNDi has engaged a reorganization process which aims at effectively implementing the recently approved business plan, and is currently looking for a Clinical Trial Manager.

 

Purpose of the position

The CTM will play an important role in the development of new drugs and treatments for mycetoma and anti-microbial resistance (AMR). S/he will be involved in the coordination, support, and documentation of a mycetoma pivotal trial throughout all stages of the development process, in accordance to Good Clinical Practices (GCP) standards, with regards to specific duties set out below. As a CTM, s/he will report to the Head of Disease. S/he will also support in coordinating activities for the Global Antibiotic Research & Development Partnership (GARDP) projects on neonatal sepsis and gonorrhoea which will include but not be limited to coordination of regional observational study and clinical trial activities for this global project. The post is Nairobi-based but frequent travel to the field especially in Sudan for the mycetoma project and within Africa and occasionally in Europe is expected.

 

Specific job responsibilities

Coordination of the clinical trials conducted by DNDi

  • Day-to-day management of the clinical trial monitors, project coordinators, and clinical research associates involved in the studies, including time-tabling site visits, review of monitoring reports, identifying and resolving issues identified during the monitoring visits, and organizing/chairing trial monitors’ meetings
  • Provide backup, support, and advice/mentorship for trial monitors including co-monitoring and substitute monitoring as and when required
  • Provide backup for the clinical medical coordinator for CRA trial safety reporting e.g. Serious Adverse Events (SAE) reporting
  • Ensure coordination of local monitoring and data management activities and provide support to the trial data management team including Trial Statistician and Data Managers
  • Liaise with DNDi Africa office Finance & Administration Managers for trial related activities and payments
  • Support and respond to requests from trial site team members and country PIs on trial related matters
  • Arrange trial specific and applicable training for trial site teams and identify training needs for collaborative sites
  • Any other duty assigned

Develop project plans

  • Develop project schedules with the Project Manager, medical coordinator and the investigators
  • Monitor milestones for project evaluation with the above project team
  • Play a full role in the R&D team and be an active member of the mycetoma and GARDP teams and DNDi organization

Ensure regulatory compliance for projects

  • Be familiar with drug development regulatory requirements, documentation, and processes for major international agencies and have thorough knowledge of the clinical development process
  • Ensure projects follow GCP and applicable regulatory requirements and keep appropriate documentation
  • Participate in preparation and submission of regulatory documentation for allocated countries
  • Prepare and review clinical SOPs and other standard documents required for clinical trials
  • Contribute to the set-up and review of DNDi systems related to clinical operations as appropriate

Manage and develop project reporting systems

  • Collect data and information to enable the Project Manager and Director DNDi ARO to make effective and cost-efficient use of DNDi resources
  • Interact with study site teams on a regular basis to ensure that projects achieve set milestones
  • Provide logistical support and tracking for all trial resources/materials with the trial monitors, trial managers, and site investigators
  • Liaise with the project consultants and collaborators within the project network
  • Compile and write a monthly and yearly project update as required
  • Under supervision of the Project Manager, be able to represent DNDi to the relevant medical authorities (Ministries of Health and drug regulatory authorities) as and when needed
  • Under supervision of the Head of Disease and medical coordinator to be able to represent DNDi in both scientific and communication events as and when needed

Manage and develop project reporting systems

  • Develop and maintain the skills required for delivery of all aspects of clinical trials
  • Maintain an awareness of all developments in the designated neglected diseases that relate to drug development and disease control
  • Be aware of developments in clinical development and the regulatory environment, and report these to DNDi

Reporting line

  • The CTM reports to the Head of Disease
  • Directly supervises the Project Coordinator, Clinical Research Associates, and Clinical Trial Monitors within his/her team

Interactions

  • To work closely with relevant disease teams

 

Job requirements

Skills and attributes

  • Very strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
  • Very clear and systematic thinking that demonstrates strong judgment and problem-solving competencies
  • Very strong communication skills in multicultural, multilingual environments
  • Very strong ability to work effectively as part of a multicultural team
  • Very well organized and structured
  • Very strong analytical skills
  • Very strong ability to lead project delivery
  • Very strong ability to manage large size projects with budget management
  • Strong strategic thinking and leadership abilities
  • Very strong management, negotiation, and advocacy skills
  • Very strong ability to exercise high degree of independence to support programme delivery and explore new areas of activities
  • Very strong ability to interact with internal and external stakeholders
  • Lead and motivate a team for optimum performance, supervising junior staff

Experience

  • Over 8 years in senior role in clinical R&D
  • Clinical experience and understanding of global issues related to antimicrobial chemotherapy is desirable
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in public and private sector is highly desirable

Education

  • S/he will have high level scientific qualifications MD/MBchB in a relevant discipline with a proven record of organizational skills
  • Master’s degree in medical or related field is an added advantage

Other requirements

  • Fluency in English
  • French would be an added advantage
  • Proficiency in local languages desirable
  • Computer skills: Excellent knowledge in software packages used in word processing, presentations, management, and finance

Other information

  • Status: Full time

 

To apply

  • Deadline for application: Accepting applications until October 13th.
  • Only shortlisted candidates will be contacted.