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Therapeutic Efficacy Consultant - (2402618) 

Contractual Arrangement: External consultant

Contract Duration (Years, Months, Days): 45 DAYS

Job Posting

: Mar 18, 2024, 11:32:46 AM

Closing Date

: Apr 1, 2024, 9:59:00 PM

Primary Location

: South Sudan-Juba

Organization

: AF_SSD South Sudan

Schedule

: Full-time 

IMPORTANT NOTICE: Please note that the deadline for receipt of applications indicated above reflects your personal device's system settings. 

..

Purpose of Consultancy

To provide quality assurance through training and clinical monitoring for the conduct of therapeutic 

efficacy studies for first- and second-line malaria medicines in countries in South Sudan

Background

Malaria remains the most significant public health problem in South Sudan accounting for 66.8%. 

of outpatient consultations, 30% admissions and 50% of deaths. About 50% of the population will 

have at least one episode of malaria annually while about 2.5 million under-fives will have 2 to 4. 

attacks of malaria annually [2]. World Malaria Report estimates that there are about 8750 malarias. 

cases daily and 20 people die of malaria daily in South Sudan. In 2017, malaria prevalence was. 

measured to be 32%. Transmission is all year round with peaks between July and November. 

Plasmodium falciparum is the dominant species accounting for 93.1 % of infections.

Malaria case management, encompassing prompt diagnosis (either by microscopy or RDT) and 

treatment with an effective antimalarial, aims to cure the patient and reduce the number of 

individuals that progress to severe disease and death. In 2015 the Ministry of Health changed the 

treatment policy for uncomplicated malaria to the Artesunate Amodiaquine Combination Therapy 

(ACT) in keeping with the WHO recommendations. Significant progress has been made in scaling. 

up the procurement and distribution of RDTs and ACTs to health facilities in the country with 

cases being managed in both public and private facilities. However, the current therapeutic 

efficacy of the first- and second-line treatment is not known. It is against this background that the 

Ministry of Health in South Sudan is planning to assess the therapeutic efficacy of artesunate. 

amodiaquine and artemether-lumefantrine treatment currently in use for management of 

uncomplicated malaria. The results of this study will be used to assist the Ministry of Health of 

South Sudan in assessing the current national treatment guidelines for uncomplicated P. 

falciparum malaria and to update the policy if necessary. The general objective of this study is to 

assess the therapeutic efficacy and safety of artesunate/amodiaquine and 

artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria in Juba, Wau 

and Rubkona, counties of South Sudan

Antimalarial drug efficacy is assessed through therapeutic efficacy studies (TES), the results of 

which are used by national malaria programmes as their primary reference to determine national? 

treatment policies. TES are conducted in a controlled environment in which drug administration. 

is supervised, the results of microscopic examinations of blood films are validated, and the origin. 

and quality of the drugs are verified. TES are prospective evaluations of patients’ clinical and 

parasitological responses to directly observed treatment for uncomplicated malaria. Studies at 

regular intervals at the same sites allow for the early detection of resistance and provide evidence. 

for guiding national malaria treatment policy.

Resistance of Plasmodium falciparum to antimalarial drugs, including artemisinin poses a serious 

threat in the fight against malaria. The threat was first reported in the Greater Mekong sub-region. 

in Southeast Asia, where resistance to artemisinin combination therapies (ACTs) has emerged. 

and spread, leading to treatment failure and an increase in malaria illness. Partial artemisinin 

resistance is mediated by mutations in the PfKelch13 propeller gene of the malaria parasite. 

Parasites with these mutations are widespread in Southeast Asia and some Pacific Islands. Since 

2018, countries in Africa have documented confirmed mutations conferring partial artemisinin 

resistance (Rwanda, Eritrea, Uganda) although these have not been shown to affect antimalarial efficacy yet because the partner antimalarial medicines remain effective. In the WHO African 

Region, the efficacy rates of artemisinin combination therapies (ACTs) for the treatment of P. 

falciparum malaria – artemether-lumefantrine (AL), artesunate amodiaquine (AS-AQ) and 

dihydroartemisinin-piperaquine (DHA-PPQ) – have remained high (over 90%). It is for this reason. 

that WHO recommends routine monitoring of efficacy of first and second line ACTs every two. 

years at sentinel sites in each country, to detect and counteract emerging threats. In vivo 

therapeutic efficacy studies (TES), although routine, should be conducted with the same rigor as 

clinical trials. 

Quality control monitoring is an essential part of the conduct of high-quality therapeutic efficacy. 

studies. By visiting study sites at the beginning, during and at the end of a study, quality control 

monitors help to ensure that a study site is appropriate, that clinical and laboratory resources are. 

adequate, that data processing is complete, and that reporting is underway. To facilitate this 

process, WHO has developed 3 separate template checklists for quality control monitoring (see 

annexes 1, 2 & 3). The templates can be used as provided or adapted according to local. 

conditions and sponsor requirements.

Clinical monitoring is mostly independent oversight provided during a clinical trial. It comprises. 

quality assurance procedural activities that commence before a trial and occur throughout the 

duration of that trial to ensure that the trial is conducted, recorded, and reported in accordance. 

with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the 

applicable regulatory requirement(s). TES Monitoring is defined as the act of overseeing the start, 

progress of the study, and of ensuring that it is conducted, recorded, and reported in accordance. 

with the approved study protocol. 

Objectives

The overall objective is to ensure that high quality therapeutic efficacy studies are conducted and 

reported to guide national treatment policy. Specifically, to:

1. To assess the readiness of the selected study sites for the conduct of the therapeutic 

efficacy studies (before the study starts). 

2. To determine / establish that procedures related to ethics, patient recruitment and follow-up, protocol compliance and case record forms (CRFs), laboratory (and microscopy) and 

data entry are adhered to according to the required standards (during the implementation 

of the study). 

3. To verify that all the procedures related to the conduct of the therapeutic efficacy studies 

in all the sites are implemented according to the required standards and the outcomes 

reported to the relevant authorities (at the end of the study). 

4. To document inadequacies in the conduct of the therapeutic efficacy study at the 

selected sites and develop an action plan to address the gaps/inadequacies. 

observed. 

5. To train site staff including national level staff on the conduct of a therapeutic 

efficacy study.

Tasks to be undertaken.

Using the WHO clinical monitoring tools, the therapeutic efficacy study protocol and any other 

standard operating procedures (SOPs) as appropriate to:

  • Facilitate training in the conduct of the therapeutic efficacy study.
  • Identify gaps and weaknesses in the conduct of the therapeutic efficacy studies at the 

various study sites and provide relevant recommendations.

  • Document inadequacies and develop action plan (s) to address the identified observed 

gaps/issues and challenges to ensure high quality conduct of the therapeutic efficacy. 

studies.

  • Conduct entry and exit meetings with the study PIs and team at central level and with the 

investigators / coordinators and other team members at each of the study sites. 

  • Provide support to the study team (s) and discuss potential solutions to any identified 

issues/challenges to be addressed by the study Principal Investigators (PIs) and team. 

members.

  • Follow – up on any issues identified during previous visits as appropriate. 

Deliverables 

1. Monitoring visit report (including agreed action plan (s) with the Study PIs and team to 

address identified inadequacies/ issues). 

2. Travel report 

Duration 

Total duration 45 days 

Seven (7) days per visit

Number of visits – Three (3) 

Specific requirements

Qualifications

Master’s degree in public health, parasitology, or infectious diseases

Experience required.

At least 3 years’ experience in the field at global or regional level with proven experience for 

design, conduct and or implementation of therapeutic efficacy studies, and in conducting training. 

in malaria case management and therapeutic efficacy studies.

Technical skills and knowledge

High level of experience in malaria case management 

Language requirements

Languages and level required (Read-Write-Speak/ Expert or Intermediate)

English/Expert

Additional Information (For HR use only):

  • This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
  • Only candidates under serious consideration will be contacted.
  • A written test may be used as a form of screening.
  • If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
  • For information on WHO's operations please visit: http://www.who.int.
  • The WHO is committed to creating a diverse and inclusive environment of mutual respect. The WHO recruits workforce regardless of disability status, sex, gender identity, sexual orientation, language, race, marital status, religious, cultural, ethnic and socio-economic backgrounds, or any other personal characteristics.

The WHO is committed to achieving gender parity and geographical diversity in its workforce. Women, persons with disabilities, and nationals of unrepresented and underrepresented Member States (https://www.who.int/careers/diversity-equity-and-inclusion) are strongly encouraged to apply for WHO jobs.

Persons with disabilities can request reasonable accommodations to enable participation in the recruitment process. Requests for reasonable accommodation should be sent through an email to reasonableaccommodation@who.int

  • An impeccable record for integrity and professional ethical standards is essential. WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter (https://www.who.int/about/who-we-are/our-values) into practice.
  • WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of short-listed candidates.
  • WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
  • Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. 
  • WHO shall have no responsibility for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
  • Please note that WHO’s contracts are conditional on members of the workforce confirming that they are vaccinated as required by WHO before undertaking a WHO assignment, except where a medical condition does not allow such vaccination, as certified by the WHO Staff Health and Wellbeing Services (SHW). The successful candidate will be asked to provide relevant evidence related to this condition. A copy of the updated vaccination card must be shared with WHO medical service in the medical clearance process. Please note that certain countries require proof of specific vaccinations for entry or exit. For example, official proof /certification of yellow fever vaccination is required to enter many countries. Country-specific vaccine recommendations can be found on the WHO international travel and Staff Health and Wellbeing website. For vaccination-related queries please directly contact SHW directly at shws@who.int.
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