Consultant – Clinical Trials

Management Sciences for Health

Management Sciences for Health (MSH), a global health nonprofit organization, uses proven approaches developed over 40 years to help leaders, health managers, and communities in developing nations build stronger health systems for greater health impact. We work to save lives by closing the gap between knowledge and action in public health. Since its founding in 1971, MSH has worked in…

Job Information

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    Duty Station Kathmandu
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    Type of Appointment Contract
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    No. of Openings 1 opening
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    Salary Negotiable / Monthly
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    Job Level : Mid-Level
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    Job Experience : 3+ years
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    Job Category Development & Project
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    Job Qualification : Master
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    Posted Date : Dec 20, 2021

Job Description

Statement of Work

Date: December 20, 2021

(Only for Nepalese Nationals)

Project name: USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program

Title: Consultant – Clinical Trials

Estimated Period of Performance: January 15, 2022 to October 30, 2022, Total LOE: 120 days

Introduction and Background:

Funded by the U.S. Agency for International Development (USAID), the Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program, implemented by Management Sciences for Health, provides pharmaceutical system strengthening assistance for sustained improvements in health system performance and to advance USAID’s goals of preventing child and maternal deaths, controlling the HIV/AIDS epidemic, and combating infectious disease threats, as well as expanding essential health coverage.

The goal of the global, five-year (2018–2023) program is to enable low- and middle-income countries to strengthen their pharmaceutical systems to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medicines and medicine-related pharmaceutical services. To achieve this goal, the MTAPS program has the following objectives:

  • Strengthen pharmaceutical sector governance
  • Increase institutional and human resource capacity for pharmaceutical management and services, including regulation of medical products
  • Improve availability and use of pharmaceutical information for decision making and advance global learning agenda
  • Optimize pharmaceutical sector financing, including resource allocation and use
  • Enhance pharmaceutical services, including product availability and patient-centered care to achieve desired health outcomes

The purpose of MTaPS is to provide pharmaceutical system strengthening assistance for sustained improvements in health system performance, and to advance USAID’s goals of Preventing Child and Maternal Deaths, Controlling the HIV/AIDS Epidemic, and Combatting Infectious Disease Threats, as well as expanding essential health coverage.

The recent WHO Global Benchmarking Tool (GBT) assessment identified the regulatory maturity level of Nepal’s regulatory agency—the Department of Drug Administration (DDA)—as low. Several measures are needed to increase the regulatory maturity of the DDA and advance the government’s goals for the pharmaceutical sector, including the regulation of clinical trials (CT).

MTaPS Nepal is supporting the Ministry of Health and Population (MoHP)/DDA to strengthen its regulatory maturity level. An action plan for the years 2021-2023 was drafted based on the DDA Business Plan 2019-2020, the WHO GBT assessment conducted in April-May 2021 and the accompanying Institutional Development Plan (IDP).

The DDA and National Medicines Laboratory (NML) maturity level action plan (MALAP) 2021-2023 reflects the steps towards attainment of Maturity Level (ML) 2 in the first year from July 2021 to July 2022 and targeting ML 3 in the second year from August 2022 to July 2023 according to WHO GBT and based on the road map developed to achieve this goal. The action plan covers all regulatory areas including CT for which activities to be implemented have been detailed.

The objective of this consultancy is to assist the DDA to implement recommended activities from the MALAP in the areas of CT towards attaining maturity level 3.

Description of services to be provided

The consultant will support MTaPS in collaborating with the DDA to:

  • Work towards increasing the GBT maturity level at least to maturity level 2 in the technical area of CT regulation according to the GBT
  • Implement the MALAP recommended activities to strengthen CT regulation.

The consultant will undertake the following activities in collaboration with DDA and MTaPS team:

  • Review the legal provisions (laws, decrees, regulations or any legal binding document) and guidelines currently in place and draft regulation for CT control. i.e., for applicants or relevant stakeholders to comply with Good Clinical Practices principles.
  • Include the requirement for stakeholders involved in CT to comply with Good Clinical Practices principles and for Investigational Medicinal Products, used in CTs, to be produced in compliance with the principles of Good Manufacturing Practices and include provisions that cover circumstances such as fast-track CT authorization in the draft regulation for CT control.
  • Draft the legal framework (laws, decrees, regulations or any legal binding document) to make provision for the DDA to recognize and use relevant CT decisions, reports or information from other regulatory authorities, regional and international bodies.
  • Draft guidelines, criteria, documentation and report requirements for the CT application and processing, including timelines.
  • Draft guidelines on non-routine CT procedures (such as fast-track) specifying the scope of the evaluation process and communication with stakeholders.
  • Draft guidance documents and application forms regarding destruction of investigational medical products.
  • Draft guidelines and regulations on monitoring and reporting of adverse events and reactions during the CT, as well as the guidance on required follow up.
  • Develop terms of reference for a CT and ethical committee.
  • Draft guidelines regarding recognition and use of relevant CT decisions, reports or information from other regulatory authorities, regional and international bodies.
  • Draft guidelines on nonclinical data requirement and the SOPs on review of the nonclinical data submitted as part of the CT application.
  • Define the DDA structures, guidelines, professional profiles, job descriptions regarding CT oversight, roles and responsibilities.
  • Assist DDA to establish a unit for CT oversight and develop training plans and train DDA staff.
  • Establish a register of approved or rejected CT applications and reports.
  • Perform other regulatory task needed to increase DDA regulatory maturity level and implement MALAP.

Required Qualification & Experience

  • Master’s degree or equivalent in pharmacy, public health, medicine, or related field
  • Minimum of 3 years of work experience in the pharmaceutical sector of low-and middle-income countries
  • Prior experience providing technical assistance to or working directly with the DDA preferred
  • Prior experience working with USAID-funded projects preferred
  • Proven experience working with stakeholders in low resource settings to identify and prioritize appropriate solutions and improvement strategies
  • Experience with establishment of the CT department’s strategy and objectives, as well as instruments and tools for implementation of CT regulation
  • Experience with maintenance of clinical trial database
  • Strong knowledge and practical experience in the design, approval, management and implementation of CT
  • Extensive knowledge of Good Clinical Practices principles and any other international best practices in CT regulation
  • Proven practical experience in evaluation of clinical trial application dossiers, inspection of clinical trial sites for Good Clinical Practices compliance
  • Knowledge and expertise in review of safety information including serious adverse events
  • Proven skills in development of SOPs and regulatory guidelines,
  • Knowledge of the Nepali legal framework and legislative process
  • In-depth knowledge of human resource requirements for CT regulation
  • Knowledge of the management and function of CT and Ethical committees
  • Ability to conduct policy and data analysis, and prepare reports and presentations
  • Ability to organize the work with minimum supervision
  • Advanced skills in Microsoft and Google suite of products
  • Excellent written and verbal communication skills in Nepali and English

How to Apply

The interested candidate possessing above qualification and experiences are requested to apply with the following details at

  • An updated CV including three references