PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. 

PATH seeks a Clinical Trial Manager (CTM) for the upcoming multi-year Unitaid-funded feasibility study in Ethiopia. The clinical trial manager (CTM) will serve a critical role in VivAction, a 4-year project aimed at providing equitable access to appropriate Plasmodium vivax (P. vivax) treatment options and reduce the global disease burden of P. vivax malaria by accelerating target country adoption of radical cure (RC) tools (drugs and diagnostics). 

This will be achieved in part through a feasibility study that will generate evidence to demonstrate the feasibility, safety and effectiveness of new P. vivax tools in Ethiopia to inform policy change. The resulting evidence will help inform both WHO and national malaria guidelines.  

The feasibility clinical trial manager will work in close collaboration with PATH, MMV, the National Malaria Elimination Program (NMEP), AHRI, the implementing partner, and other national and regional stakeholders. The core responsibilities of this role include assuming responsibility for overall study management, for compliance with applicable research quality and regulatory framework, and executing the study in collaboration with partners on time and on budget.  

MAIN RESPONSIBILITIES: STUDY PLANNING AND MONITORING  

• Develop and execute a clinical study agreement with the implementing partner. 
• Support the PATH team to engage with the NMECP to ensure that the feasibility study will contribute to the evidence needed for the MOH policy adoption of G6PD test and appropriate radical cure. 
• Manage the study’s implementing partner – development of project budgets, timelines, and activities.
• Lead discussions and engagement with key stakeholders, including local health authorities.
• Support the development of the study protocol including site selection. 
• Prepare submission packages for local IRB; coordinates responses to local IRBs following review in close collaboration with Study Team Lead
• Adapt existing training materials for use in the study and coordinate all necessary study trainings. 
• Develop and update study timelines, monitors study progress and milestones. 
• Liaise with the global study team and the broader project leadership team ensure study timelines/budget feed into Overall Global Studies timelines and budget.
• Draft and circulates monthly study progress reports and update monthly country dashboard.
• Develop and updates study RACIs.
• Develop and update detailed study budget; check invoices against agreed budget before submitting for formal MMV approval and processing by Finance.
• Lead development and implementation of risk management plan with support from global study team 
• Coordinate development and facilitate review of study documents (protocol, ICF, CRF, patient cards, etc…)
• Develop recruitment projections and monitor recruitment rates throughout the study.
• Develop forecasting for study supplies.
• Work with data management service provider to produce interim analysis reports upfront of ISOC meetings.
• Ensure compliance with Ethics standards and SOPs regarding study documentation.
• Track and monitor progress with data collection; escalate any issue with data management.
• Support the development of advocacy materials. 
• Represent PATH and the Vivaction project at national and regional meetings. 
• Provide ad-hoc meeting support when needed, e.g. discussions with National Regulatory Authorities, meeting with the NMEP etc.  
• Support the scientific community in the region on relevant research projects that support evidence for the adoption of new tools for malaria control.

Required Skills Required Experience

• Medical doctor or Master’s level qualification in public health, Epidemiology or related disciplines. 
• 15-year experience out of which 5-7 years of relevant experience in public health in the field of research and survey, preferably experience in clinical research. 
• Demonstrated experience making significant contributions to clinical studies or operations research design and implementation. 
• Proven experience working in or with disease control programs, building relationships with high-level government stakeholders within ministries of health. 
• Experience working on health commodity procurement and supply chain management in Ethiopia. 
• Knowledge of pharmacovigilance 
• Direct experience working in field research, specific experience with malaria is a plus

TECHNICAL SKILLS REQUIRED.  

• Verbal and written fluency in English and Amharic is essential. 
• Strong report-writing skills, particularly with regards to donor reporting requirements. 
• Experience conducting or organizing clinical studies. 
• Excellent organizational and project management skills. 
• Familiarity with global health issues.

BEHAVIORAL SKILLS REQUIRED.  

• Excellent written and oral communications skills. 
• Ability to engage effectively with high-level government stakeholders. 
• Ability to multi-task, set priorities, and work independently. 
• Strong interpersonal and collaboration skills. 
• Cultural sensitivity and awareness. 
• Willingness to travel frequently (up to 25% of time) in the country, region and internationally.

Application deadline is on Friday 7th May 2021. Only short-listed candidates will be contacted.     

To apply for this position, please visit the PATH Careers page or send copy of your credentials and cover letter using the below address to PATH office in Ethiopia within 10 working days.

PATH OFFICE IN ETHIOPIA

P.O. BOX 493 CODE 1110

ADDIS ABABA, ETHIOPIA.

Candidates must have legal authorization to work in Ethiopia.

PATH is dedicated to building an inclusive workforce where diversity is valued.

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

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