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Incumbent is responsible for coordinating efforts of cross-functional project teams within the Clinical Directorate of the U.S. Military HIV Research Program (MHRP, www.hivresearch.org). Under the direction of the Clinical Directorate, the incumbent will work with a team of project managers to develop project plans and support budget development activities, track progress of assigned programmatic research studies under the Clinical Directorate, and organize communication with study teams located in the U.S. and internationally and integrate administrative activities supporting clinical research projects. MHRP sites are located in Uganda, Kenya, Tanzania, Nigeria, and travel is required. The clinical project manager will work with multiple research physicians, but under the guidance of one coordinating research physician. Type of studies may include PEPFAR funded observational studies under the African Cohort Study (AFRICOS) objectives. The clinical project manager may assist with site activities, working with HJF teams to establish project timelines and coordinate research portfolios.
1. Responsible for operational management of clinical research by applying comprehensive knowledge of clinical development and project management to help lead and develop appropriate project plans, work with the project team to refine plans and establish realistic targets for task completion, develop and implement communications plans, and monitor progress throughout the life of the study.
2. Support research physicians and project lead by coordinating operational, administrative and diverse programmatic activities for the Clinical Research Directorate/AFRICOS Group for multi-site international programmatic studies. Project teams may include research physicians, statisticians, pharmacists, data managers, regulatory specialists, site PI and study teams, clinical and research laboratory experts, research collaborators, human resources, budget analysts, and contracting.
3. Coordinates with team leads in each project area to prepare written progress reports and oral briefings on study-related timelines and milestones. Track and support study budget development and track any required project agreements and contracts with the MHRP/AFRICOS Group’s finance point of contact.
4. Coordinates communications within project team, organizing meetings and developing appropriate agendas, coordinating meeting minutes and their appropriate dissemination, following up on action items with responsible parties. Support the Research Physicians by assisting with meeting management and the development of plans, reports and presentations as required.
5. Assess risks to project performance, and independently or in collaboration with study team, develop risk mitigation proposals for consideration by responsible leadership. Implement selected mitigation plan(s) and monitor outcomes
6. Liaise and work with project area leads to ensure development of necessary study documentation, clinical database, CRFs and ICFs. Liaise with clinical operations team lead to ensure the development of and adherence to operations documents and procedures. Liaise with regulatory team lead to ensure compliance with regulatory jurisdiction of each site and all applicable US agencies.
7. Assists Research Physicians with site development including establishing site development and logistics.
8. Performs other related duties as assigned.
Required Knowledge, Skills, and Abilities: Ability to work in a fast-paced international research environment, and to plan and manage multiple priorities on different timelines. Ability to incorporate strategic vision of leadership into plans and operations with attention to details leading to optimized cost, time and performance outcomes. Ability to manage complex issues with multiple partners and stakeholders. Flexibility to handle a variety of tasks and shift priorities as necessary. Excellent organization, time and project management skills with strong interpersonal skills. Ability to effectively interact with local and international external collaborators in a culturally sensitive manner. Ability to work as an effective team member in a virtual environment. High level of initiative and ability to work with minimal supervision. Demonstrated clinical project management ability, oral/written communication, presentation, and interpersonal skills. Proficiency in standard project management software and budgeting tools is preferred.
Education/Training Requirements: Master’s Degree required, MPH preferred with experience in clinical research or clinical operations positions, progressively leading to clinical project management role. Familiarity with requirements of International Conference on Harmonization of Good Clinical Practice.
Minimum Experience: 3-6 years clinical research experience, with at least 2 years in a project management role as a team leader. Training or experience in implementation science and observational studies in an African setting is highly desirable.
Physical Capabilities: Ability to travel up to 30% of time to international field sites.
Required Licenses, Certification or Registration: Project Management certification desirable, but not required.
Work Environment: Office environment; Occasional on-site work at international field sites.