Clinical Trial Manager

Clinical Trial Manager

Barcelona Institute for Global Health

Barcelona, Spain

Background

Malaria remains a public health problem across the developing world. After achieving remarkable advances from 2000 to 2015, the global fight against malaria has stalled. The World Malaria Report 2018 estimates an increase to 219 million cases in 2017 compared to 216 million in 2016. We are currently not on track to achieve the goals proposed by WHO in the Global Technical Strategy for Malaria 2016-2030 (GTS).


Vector control, our most effective prevention strategy, is now doubly threatened by residual transmission and insecticide resistance. New tools are needed to control residual transmission, one of the key liabilities of vector control today.


Ivermectin is an endectocide, a drug with excellent safety profile that can kill ecto- and endo-parasites, as well as mosquitoes fed on treated humans or animals. Mass drug administration (MDA) of ivermectin to humans and/or livestock holds the potential to complement the malaria toolbox by tackling residual transmission and help overcoming insecticide resistance. 


The project

BOHEMIA is a Unitaid funded, 4-year project that combines evidence generation and stakeholder engagement to create an enabling environment for ivermectin as a first-in-class endectocide for malaria prevention. This will be achieved by generating evidence to support a WHO policy recommendation, briefing and engagement of country and regional leaders and civil society in order to forge country ownership and create demand, as well as ensuring supply of quality product by enabling manufacturer engagement as suppliers of quality, high volume/low cost product sufficient for malaria indication.


Evidence generation will consist of two independently powered cluster-randomized clinical trials in Tanzania and Mozambique with analysis of impact on infection incidence, as well as supporting entomological outcomes.


The institution

ISGlobal – Barcelona Institute for Global Health is a research center in international health whose ultimate goal is to help close the gaps in health disparities between and within different regions of the world. For this, we leverage on knowledge generation (research), transmission (training) and application (policy and global development). ISGlobal is a WHO Collaborative Center for Malaria Elimination and Eradication.


ISGlobal is looking for an experienced Clinical Trial Manager for the BOHEMIA project. 


Job title: Clinical trial Manager (CTM)

Reports to: BOHEMIA Principal Investigator (PI) / Chief Scientific Officer (CSO)


The CTM will work closely with the Project Manager and the Financial Manager who are respectively responsible for the overall project tracking, and budgets/accounting.





Essential duties and responsibilities


Ensures that all human subject research activities that will be done under BOHEMIA are conducted under standards of Good Clinical Practices/ICH as per ISGlobal’s SOPs

Supports the clinical research teams at headquarters and site levels in the full spectrum of the trial including:

Protocol development

Obtaining Ethical and regulatory approval for the trial prior to study site initiation

Trial management activities from start up to close out

Development of trial tools and templates

Management of clinical trial monitors

Review and approval of monitoring reports

Review and approval of monitor timesheets and expenses

Site management and closure

Trial tracking

Verify that all subject research activities undertaken in field sites as part of the BOHEMIA project are conducted according to the standards of ICH-Good Clinical Practice, international and local regulations. 

Receives and takes appropriate action following monitoring reports

Oversees and coordinates study drug supply from procurement to delivery on site, including the required documentation.

Maintains responsibility for the Trial Master File and archiving of thereof, for the correct filing and archiving of clinical trial documents, and the maintenance of study files.

Coordinates, manages and participates in clinical trial meetings 

Provides project status updates and reports to the PI/CSO as required

Risk identification and escalation to the PI/CSO 

Issue identification and applicable escalation to the PI/CSO 

Participates in site selection and initiation visits and assists with HSR training of field staff.

Attends consortium and other meetings as required. Presents data as required.

Contributes to funder reports


Qualifications


Excellent communications and collaboration skills, experience working in diverse cultures

Required: 

At least 5 years of experience across all stages of the clinical trial lifecycle, i.e. from protocol development to final study report. Experience managing clinical trials funded from the commercial and development funding sectors, site development and support trial/s under first-tier regulatory review

Management of clinical trial teams

Minimum of BSc or health/science degree equivalent

Current ICH/GCP certification

Excellent written and spoken English 

Willingness to travel to sites in Africa

Preferred:

Previous experience in field trials

Previous experience in prevention trials, either drugs or vaccines

Working experience in Portuguese/Spanish


Additional skills

Results-oriented approach to problem solving

High professional standards for clinical trial execution, monitoring and reporting

Accustomed to team work and willingness to contribute to elements outside the clinical trial scope

Ability to work under pressure

Ability to work independently where necessary


This position requires international travel, including site visits to rural Tanzania 

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Position

Clinical Trial Manager