Consultant on Clinical Trial

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 countries 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 that rights and well-being of human participants are protected. WHO provided support by facilitating 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 by a pandemic situation, where the “standard” clinical trials design and execution are not applicable because the world is racing against time.

The consultant will support the work of WHO in strengthening clinical trial oversight 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.

PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY

To support the regulatory systems strengthening programme within EMT team in the development and implementation of strategies and actions in strengthening Member States' clinical trial oversight with particular focus on COVID-19 vaccine introduction in the Western Pacific Region.

METHODS TO CARRY OUT THE ACTIVITY

Under the supervision of the Coordinator, EMT and Medical Officer, RSS, the consultant is expected to deliver the following:

Outputs

Output 1: Monitor clinical trial developments of therapeutics and vaccines against infectious diseases and present to NRAs and other partners.

Deliverable 1.1: Monitoring sheet updated regularly

Deliverable 1.2: Presentation slides, briefing notes on research and development

Output 2: Support in implementing global benchmarking process and institutional development plans of the countries focusing on clinical trials oversight.

Deliverable 2.1.: Workplan for the implementation of priority countries Institutional Development Plan and meeting reports

Output 3: Assist in the review and development of country-specific guidelines for clinical trial oversights

Deliverable 3.1: Review of guidelines of selected countries on clinical trial oversight

Output 4: Lead the capacity building activities for clinical trials (e.g. development of e-learning courses, facilitating trainings-regional or country support)

Deliverable 4.1: Concept note of e-learning courses, planned training activities

Output 5: Assist in partnership and stakeholder coordination, participation to technical meetings within WHO and external partners

Deliverable 5.1: Meeting materials and reports

QUALIFICATIONS & EXPERIENCE

EDUCATION

Essential:  Advanced university degree in pharmaceutical sciences, public health or other related health sciences from an accredited/recognized institution.

Desirable:  Postgraduate degree in regulatory sciences.

EXPERIENCE

Essential:  More than 3 years of proven professional and working experience in clinical trials of medical products.

Desirable:  Developing and managing systems within a medicine regulatory authority in developing countries and/or ASEAN countries and experience on benchmarking of National Regulatory Authorities and provision of trainings on clinical trials.

TECHNICAL SKILLS & 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 medical products (e.g. review of product dossiers 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

LANGUAGES

Essential: Fluent in English (writing, reading 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

ADDITIONAL INFORMATION

Contract duration           

5.5 months starting 15 July 2022

Place of assignment

The consultant will be based in WPRO, 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.

All travel arrangements will be made by WHO – WHO will not be responsible for tickets purchased by the Consultant without the express, prior authorization of WHO. While on mission under the terms of this consultancy, the Consultant will receive subsistence allowance.

Visas requirements: it is the consultant’s responsibility to fulfil visa requirements and ask for visa support letter(s) if needed.

APPLICATIONS

Qualified and interested specialists should submit their CV {for individual contractors} and Expression of Interest {cover letter} to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 7 July 2022. 

The cover letter should outline how their experience and qualifications make them a suitable candidate for this position and should include their proposed daily consultancy fee and availability.

Please use Tender Notice No. 177049 as subject to all submission. Only successful candidates will be contacted.