Consultant - clinical trialWorld Health Organization

Purpose of the Consultancy
To support the regulatory systems strengthening programme within the Essential Medicines and Health Technology Unit team in the development and implementation of strategies and actions in strengthening Member States' clinical triavel oversight with particular focus on COVID-19 vaccine introduction in the Western Pacific Region.
Background
Clinical trials are conducted as part of the medical products development before marketing authorization. Developers and manufacturers are extensively conducting clinical trials for medicines and vaccines in many countries. However, some crountires with weak regulatory capacity face significant challenges in ensuring ethical and safe research, as they lack the needed infrastructure and skilled investigators.
WHO has been taking an active role in supporting Member States to ensure that well-conducted, blind randomized controlled trials (RCTs) are carried out and most importantly, to ensure tha rights and well-being of human participants are protected. WHO provided support by facilitaring good decision-making processes, technical competency development, establishing norms and standards. However, challenges are persistent because of various reasons including: changing regulatory landscape brought about by globalization, innovation and sophistication of health systems and the persistent lack of technical competence. These challenges have been aggravated bya pandemic situation, where the "standard" clinical trials design and execution are not applicable because the world is racing against time.
The consultant wil support the work of WHO in strengthening clinical trial oversign in the region, especially for low-and middle-income countries and to ensure that the significant learnings from the current COVID-19 situation can be integrated with the Institutional Development Plans of the country in responding to future pandemic situation and health emergencies.
Planned timelines
(5 months with possibility of extension; subject to confirmation)
Start date: 30 November 2021
End date: 30 March 2022
Work to be performed
Under the supervision of the Coordinator, EMT and Medical Officer, Regulatory Systems Strengthening, the consultant is expected to deliver the following:
Output/s
Output 1: Monitor clinical trial developments of COVID-19 therapeutics and vaccines and present to National Regulatory Authorites and other partners
Deliverable 1.1: Monitoring sheet updated regularly
Deliverable 1.2: Presentation slides, briefing notes on research and development
Output 2: Support WHO and countries in facilitaring WHO solidarity trials on therapeutics and vaccines.
Deliverable 2.1: Briefing reports on solidarity trials including (number of countries participating, meeting reports)
Output 3: Support in implementing global benchmarking process and institutional development plans of the countries focusing on clinical trials oversight.
Deliverable 3.1: Workplan for the implementaiton of priority countries Institutional Development Plan and meeting reports
Output 4: Assist in the review and development of country-specific guidelines for clinical trial oversights
Deliverable 4.1: Review of guidelines of selected counrties on clinical trial oversight
Output 5: Lead the capacity building activities for clinical trials (e.g. development of e-learning courses, facilitating trainings, regional or country support)
Deliverable 5.1: Concept note of e-learning courses, planned training activities
Output 6: Assist in partnership and stakeholder coordination, participation to technical meetings with Essential Medicines and Health Technologies, Vaccine-Preventalbe Diseases and Immunization and other relevant Officers in WHO and external partners
Technical Supervision
The selected Consultant will work on the supervision of:
Responsible Officer: Dr Jinho Shin
Manager: Dr Socorro Escalante
Specific Requirements:
Education:
Essential: Advanced univeristy degree in pharmaceutical sciences, public health or other related health sciences from an accredited/recognized institution
Desired: Postgraduate degree in regulatory sciences
Experience:
Essential: more than 10 years of proven professional and working experience in regulation of medical products
Desirable: Developing and managing systems iwthin a medicine regulatory authoritiy in developing countries and/or ASEAN countries and experience on benchmarking of National Regulatory Authorities and provision of trainings on clinical trials.
Skills/Technical skills and knowledge:
Proven ability to plan and implement new strategies and activities to achieve a goal
Ability to function effectively and effective communication skills
Sufficient knowledge on regulation of medicla products (e.g. review of product dosisers for quality, safety and efficacy, pharmacovigilance, clinical trials, regulatory inspections, laboratory access and lot release, and market surveillance)
Ability to work effectively with national regulatory authority experts and stakeholders
Language requirements:
Essential: Fluent in English (writing, readng and speaking)
Competencies:
Good understanding of the overall regulatory systems of medical products
Producing results
Moving forward in a changing environment
Fostering integration and teamwork
Knowing and managing yourself
Place of assignement:
The consultant will be based in WHO, Manila, Philippines
Medical Clearance:
The selected Consultant will be expected to provide a medical certificate of fitness for work
Travel
Depending on the situation, travel to countries in the Region may be arranged as necessary
Qualifications
Purpose of the Consultancy
To support the regulatory systems strengthening programme within the Essential Medicines and Health Technology Unit team in the development and implementation of strategies and actions in strengthening Member States' clinical triavel oversight with particular focus on COVID-19 vaccine introduction in the Western Pacific Region.
Background
Clinical trials are conducted as part of the medical products development before marketing authorization. Developers and manufacturers are extensively conducting clinical trials for medicines and vaccines in many countries. However, some crountires with weak regulatory capacity face significant challenges in ensuring ethical and safe research, as they lack the needed infrastructure and skilled investigators.
WHO has been taking an active role in supporting Member States to ensure that well-conducted, blind randomized controlled trials (RCTs) are carried out and most importantly, to ensure tha rights and well-being of human participants are protected. WHO provided support by facilitaring good decision-making processes, technical competency development, establishing norms and standards. However, challenges are persistent because of various reasons including: changing regulatory landscape brought about by globalization, innovation and sophistication of health systems and the persistent lack of technical competence. These challenges have been aggravated bya pandemic situation, where the "standard" clinical trials design and execution are not applicable because the world is racing against time.
The consultant wil support the work of WHO in strengthening clinical trial oversign in the region, especially for low-and middle-income countries and to ensure that the significant learnings from the current COVID-19 situation can be integrated with the Institutional Development Plans of the country in responding to future pandemic situation and health emergencies.
Planned timelines
(5 months with possibility of extension; subject to confirmation)
Start date: 30 November 2021
End date: 30 March 2022
Work to be performed
Under the supervision of the Coordinator, EMT and Medical Officer, Regulatory Systems Strengthening, the consultant is expected to deliver the following:
Output/s
Output 1: Monitor clinical trial developments of COVID-19 therapeutics and vaccines and present to National Regulatory Authorites and other partners
Deliverable 1.1: Monitoring sheet updated regularly
Deliverable 1.2: Presentation slides, briefing notes on research and development
Output 2: Support WHO and countries in facilitaring WHO solidarity trials on therapeutics and vaccines.
Deliverable 2.1: Briefing reports on solidarity trials including (number of countries participating, meeting reports)
Output 3: Support in implementing global benchmarking process and institutional development plans of the countries focusing on clinical trials oversight.
Deliverable 3.1: Workplan for the implementaiton of priority countries Institutional Development Plan and meeting reports
Output 4: Assist in the review and development of country-specific guidelines for clinical trial oversights
Deliverable 4.1: Review of guidelines of selected counrties on clinical trial oversight
Output 5: Lead the capacity building activities for clinical trials (e.g. development of e-learning courses, facilitating trainings, regional or country support)
Deliverable 5.1: Concept note of e-learning courses, planned training activities
Output 6: Assist in partnership and stakeholder coordination, participation to technical meetings with Essential Medicines and Health Technologies, Vaccine-Preventalbe Diseases and Immunization and other relevant Officers in WHO and external partners
Technical Supervision
The selected Consultant will work on the supervision of:
Responsible Officer: Dr Jinho Shin
Manager: Dr Socorro Escalante
Specific Requirements:
Education:
Essential: Advanced univeristy degree in pharmaceutical sciences, public health or other related health sciences from an accredited/recognized institution
Desired: Postgraduate degree in regulatory sciences
Experience:
Essential: more than 10 years of proven professional and working experience in regulation of medical products
Desirable: Developing and managing systems iwthin a medicine regulatory authoritiy in developing countries and/or ASEAN countries and experience on benchmarking of National Regulatory Authorities and provision of trainings on clinical trials.
Skills/Technical skills and knowledge:
Proven ability to plan and implement new strategies and activities to achieve a goal
Ability to function effectively and effective communication skills
Sufficient knowledge on regulation of medicla products (e.g. review of product dosisers for quality, safety and efficacy, pharmacovigilance, clinical trials, regulatory inspections, laboratory access and lot release, and market surveillance)
Ability to work effectively with national regulatory authority experts and stakeholders
Language requirements:
Essential: Fluent in English (writing, readng and speaking)
Competencies:
Good understanding of the overall regulatory systems of medical products
Producing results
Moving forward in a changing environment
Fostering integration and teamwork
Knowing and managing yourself
Place of assignement:
The consultant will be based in WHO, Manila, Philippines
Medical Clearance:
The selected Consultant will be expected to provide a medical certificate of fitness for work
Travel
Depending on the situation, travel to countries in the Region may be arranged as necessary
World Health Organization

Manila City, Metro Manila
Permanent
Full-time