Organization:Partners in Health
endTB (Expand New Drug Markets for TB) is funded by Unitaid and implemented by consortium partners Médecins Sans Frontières (MSF) and Interactive Research and Development (IRD). The endTB project is studying the use of new TB drugs in an observational study and a clinical trial. The endTB observational study is a multi-center prospective study on the safety and efficacy of multidrug-resistant tuberculosis (MDR-TB) treated with multidrug regimens containing bedaquiline or delamanid. The study is ongoing in 17 countries and will enroll approximately 2600 patients. The endTB clinical trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB).
The endTB Study Manager will supervise all aspects of the endTB observational study, including logistics, research regulatory processes, clinical operations, laboratory processes, and data quality control/assurance. This position will serve as the link between clinical operations and study implementation for the endTB observational study. This position will report to the endTB Project Manager.
The Study Manager will be primarily responsible for supervising the implementation of the observational study protocol at the PIH sites of Peru, Lesotho, Kazakhstan, Ethiopia, and Haiti. The Study Manager will work closely with the endTB co-Leads, endTB Research Assistants and the study coordinators at each site. Additional support may be provided to endTB partners who are implementing the study protocol at sites in DPRK. The Study Manager will collaborate closely with counterparts at MSF and IRD in the interest of uniform implementation of the study protocol across all endTB sites. The Study Manager will work closely with the endTB Data Manager to ensure high quality data collection for the endTB observational study.
Please note: this is a grant-funded position, ending March 31, 2019 with the possibility of extension.
- Manage all study processes, including tracking tasks, timelines and progress to ensure all study requirements are met.
- Supervise development and regulatory approvals of study protocol(s) and associated study documents at the central level and at PIH sites, with strict version control; coordinate changes with MSF and IRD counterparts
- Participate in the development and maintenance of standard operating procedures.
- Supervise study activities across investigators and sites, including clinical operations, pharmacy and laboratory activities, finance, data management, quality assurance, regulations, and logistics.
- Perform ongoing research systems analysis and identify areas needing improvement and suggest working solutions.
- Document all solutions and share as relevant across endTB sites. Ensure standardization of study activities and training across sites; oversee multi-center research aspects to prepare for internal and external audits, monitoring, regulatory/site visits, and inspections.
- Perform documentation related to these activities. Coach and support endTB Research Assistants on site operations issues.
- Work with the endTB Project Manager, Financial Manager and Data Manager to produce reports for various funders and organizations.
- Travel to PIH sites for research meetings, study process planning, and training of site staff in study processes, including EMR data entry, quality control, and quality assurance on behalf of data manager. * Approximately 25% FTE will be travel to PIH sites.
- Coordinate production of reports and dissemination of research.
- Represent the endTB observational study at external fora, preparing or delivering presentations and articles.
- Additional research-related responsibilities assigned as needed.
- Advanced degree in the health sciences, public health or a related field.
- At least 5 years of relevant research management experience.
- Experience managing research projects in low resource settings strongly preferred.
- Excellent written and verbal communication skills.
- Works well in a culturally and professionally diverse setting.
- Ability to travel approximately 25% of the time.
- Strong interest in social justice, healthcare and international development.