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GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Division of Infectious Diseases at Massachusetts General Hospital is at the forefront of innovative international clinical trials overseen by the Chief of Infectious Diseases, Dr. Ruanne Barnabas, and the Nurse Manager of the Infectious Diseases Clinical Research Unit. Dr. Barnabas brings a wealth of experience, having successfully concluded numerous international clinical trials that have catalyzed policy changes in various regions of Africa, notably addressing challenges in HPV and HIV access to care. In the year ahead, we look forward to implementing a clinical trial evaluating the efficacy of a single-dose HPV vaccination in women living with HIV, working alongside our collaborators in Rwanda, Botswana, and South Africa.
As a Senior Research Program/Project Manager, you have a unique opportunity to work with international collaborators across the globe and play a key role in research program administration, including supervision of research activities, regulatory management, and training of local and international research staff. In addition, you can actively contribute to projects as a researcher if you are interested.
Our team seeks individuals who embody a mission-driven ethos, display intellectual curiosity, exhibit meticulous attention to detail, are highly organized, and possess a deep understanding of the international clinical trial process. A sense of humor is a must. We are committed to fostering, cultivating, and preserving a diversity, equity, and inclusion culture. This commitment applies to staff members at all levels and the diverse patient populations we serve.
Example projects include:
* Evaluating delivery methods for optimizing pre-exposure prophylaxis (PrEP) access in South Africa
* An observational study evaluating the clinical impact of a policy change to allow stable HIV patients to pick up medications at community venues in South Africa
* Investigation of the role of maternal HIV infection and co-infection with early childhood infections
APPLICATION PROCESS
**When applying, please upload a cover letter and resume. Applications that do not include both components will NOT be considered.**
PRINCIPAL DUTIES AND RESPONSIBILITIES:
In collaboration with the nurse manager and physician investigator, the Program Manager/Project Manager is responsible for implementing and conducting international clinical trials for two or more study protocols. Responsibilities include, but are not limited to, the following activities:
Senior Program Management
* Work with programmatic leadership and research assistants alike to formulate and implement strategic approaches to ensure successful trial execution.
* Work with recruiting team to recruit new research assistants as needed and facilitate recruitment efforts at in-country sites by participating in job description development, posting employment opening advertisements in setting-appropriate channels, screening applicants, and interviewing selected candidates.
* Assist with the supervision of the research assistants, including:
o Develop curriculum and deliver new employee training,
o Provide daily oversight and direction,
o Meet weekly with each research assistant,
o Facilitate career development opportunities,
o Lead annual performance review process.
* Lead and inspire cross-functional project teams, fostering a collaborative and high-performance culture.
* Effectively communicate projects goals, expectations, and updates to internal and external stakeholders.
* Coordinate with key stakeholders, including investigators, vendors, and regulatory agencies.
* Ensure research integrity, including data documentation and data management, by developing best practices, provide ongoing training, and monitoring for adherence.
* Manage and participate in collaborative grant-writing projects.
Senior Research Project Management
* Develop comprehensive project timelines, budgets, and deliverables in collaboration with cross-function teams.
* Coordinate all administrative aspects of multiple active and pending projects.
* Throughout project duration, plan, track, and report on project tasks, responsible parties, timelines, etc.
* Proactively take steps to help others move forward, delegate project tasks among project team, hold project-specific meetings, bring in additional resources as needed, etc.
* Implement and maintain rigorous quality control measures throughout the clinical trial lifecycle.
* Conduct regular regulatory reviews and audits to ensure Good Clinical Practice compliance with quality standards.
* Serve as a liaison between team members at various US and international collaborative research sites.
* Coordinate and monitor Institutional Review Board applications and reporting for international projects, including all applicable review dates and deadlines to prevent lapses in approval.
* Serve as the liaison between the MGB Human Subjects Research Committee and in-country IRB and ethics boards to ensure complete, accurate, and consistent regulatory submissions.
* Create and maintain REDCap databases including the design of data collection forms, extraction and uploading of datasets, and creation of reports.
* Provide regular updates to senior management on projects status, progress, and potential risks.
Research (optional)
* Contribute directly to and/or lead scientific analysis, abstract submissions, and manuscript development for 1-2 projects at a time
QUALIFICATIONS:
Job qualifications include the following:
* 5+ years of experience in an academic, clinical research, or related setting
* Experience in international settings is required
* Bachelor's degree required; Master's degree in public health, public policy, management, or related field strongly preferred
DESIRED SKILLS/ ABILITIES/ COMPETENCIES:
Planning, Organizing and Coordinating
* Skilled in identifying opportunities to improve efficiency of research operations and subsequently execute improvements.
* Time management skills with the capability to prioritize among multiple requests from multiple individuals and the ability to change direction in response to a fluctuating work environment.
Team Management
* Strong leadership and interpersonal skills.
* Ability to work successfully in a collaborative environment.
* Ability to manage diverse teams with different skillsets, work styles, and professional roles
Gets Results/Takes Initiative
* High personal work standards and sense of urgency about results.
* Ability to anticipate the needs of the group in a fast-paced environment
* Problem-solving ability, including the ability to gather information, identify resources, and imagine alternatives
* Demonstrates initiative and identifies key priorities, even in ambiguous situations with limited direction
* Ability to work effectively under pressure and within short time constraints
* Consistently demonstrates a positive, "can-do" attitude
Communication Skills
* Excellent written and verbal communication skills
* Ability to represent the Division with the utmost professionalism and ability to build strong relationships inside and outside the group
* Ability to clarify and distill complex issues to a variety of stakeholders
* Cognizant and respectful of cultural differences in communication approach
Analytical Skills
* Intellectual curiosity and willingness to learn
* Rigorous academic and/or professional background including healthcare work
* Basic familiarity with health outcomes/epidemiology research and/or clinical trials
This description has been designed to indicate the general nature and level of work performed by an employee within this position. The actual duties, responsibilities and qualifications may vary based on need.
WORKING CONDITIONS:
Duties will be carried out in a typical office environment. Occasional evening or weekend work may be required.
Occasional travel to international research sites may be required. There is also the opportunity to travel to scientific meetings to present research.
SUPERVISORY RESPONSIBILITY:
The candidate will be responsible for providing daily supervision, guidance, and expertise for Research Assistants.
The above is intended to describe the general contents and requirements of work being performed by people assigned to this classification. It is not intended to be construed as an exhaustive statement of all duties, responsibilities or skills of personnel so classified.
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.