We are seeking a Sr. Research Program Manager, SMART4TB . This is a grant-funded position for Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB), a USAID-funded initiative to improve global TB control. The Manager will support one of the most important studies for SMART4TB, the Bedaquiline Roll-out Evidence in Contacts and People Living with HIV to Prevent TB (BREACH-TB). BREACH-TB is a phase III, open-label, multicenter, randomized, controlled, non-inferiority trial. The main objectives are to find out if treating people living with HIV and adults, adolescents, children, and pregnant close contacts of all forms of TB disease (drug resistant and drug susceptible) with bedaquiline has the same effect as standard of care treatment for reducing new cases of TB disease.

　　The Manager is responsible for assisting with planning, implementing, and monitoring the BREACH-TB study in 15-20 research sites around the world, from protocol design to the final clinical study report, while adhering to scope and timeline requirements, and assuring compliance with applicable regulations including GCP. They will assist the study leadership in managing the scientific implementation of the BREACH-TB study, and act as a liaison for the study with the Protocol Team, international sites, regulatory agencies, study monitors, and administrators. They will assist with aspects of protocol development, initiate and create case report forms, design the Manuals of Operation, and oversee development of Standard Operating Procedures at the site level. They will work with site coordinators to respond to queries, reply to monitoring reports, and facilitate communications with the data management team. They will prepare communications with institutional review boards, as well as communicate with regulatory and funding agencies, and other duties as assigned. They will plan and organize international activities, site visits, study initiation, and clinical monitoring for BREACH-TB. International travel will be required several times annually, depending on study progress and international public health advisories.

　　Specific Duties & Responsibilities

　　Project Management & Implementation

　　Contribute to the development of the BREACH-TB clinical protocol, informed consents and clinical study reports; prepare/review clinical trial documents including project agreements, CRFs and study plans/manuals, as appropriate.

　　Coordinate operational aspects of the study implementation and daily operations, from protocol design to the final clinical study report.

　　Define timelines for study start-up and apply knowledge to evaluate progress.

　　Maintain communications with a multi-disciplinary trial team made up of both internal and external team members, including but not limited to the study clinicians, site staff, contractual clinical monitor(s), vendors, data managers, and administrative staff.

　　Identify and anticipate potential study management or operations issues and collaborate with investigators and research staff to resolve these barriers to the study’s success.

　　Develop or oversee the development of training materials, including site initiation visit materials, clinical examination-specific trainings, and other trial-specific training opportunities, in consultation with investigators.

　　Conduct at least quarterly in-person or virtual site visits to monitor operations and provide quality assurance oversight to preserve the rights and safety of research participants.

　　Propose and negotiate alternatives to improve project implementation as needed.

　　Provide overall management to ensure that safety concerns and/or Adverse Events/SAEs and protocol deviations are properly reported and tracked

　　Coordinate with data management team to compile and disseminate regular trial status updates to the Principal Investigator and Protocol Team.

　　Oversee monitoring activities and escalate critical issues to the Principal Investigator.

　　Collaborate with Contract Research Organization (CRO) monitors to foster a productive and effective working relationship.

　　Initiate and conduct periodic review and revision of the Manual of Operations and site level SOPs to assure compliance with GCP and ICH policies.

　　Develop agendas for regular multi-site teleconferences. Prepare and distribute meeting minutes in a timely manner.

　　Regulatory

　　Implement a robust quality management system to ensure compliance with JHU and USAID requirements.

　　Serve as the primary resource for all BREACH regulatory matters.

　　Prepare submissions to institutional review boards for study protocols, using IRB submission platforms, and respond to queries, in consultation with the Principal Investigator.

　　Contribute to the research team in preparing abstracts and presentations related to research projects.

　　Perform other related functions, as assigned.

　　Supervisory Responsibilities

　　Orient and train new staff on BREACH study materials, including JHU and international research site staff.

　　Provide guidance and mentorship to junior investigators and coordinators on international research implementation.

　　Supervise all BREACH study staff based at JHU.

　　Minimum Qualifications

　　Master's Degree in related discipline.

　　Eight years related experience including significant experience in field conducting large research projects.

　　Experience in writing protocols and informed consent documents, data analysis, grant writing, and manuscript preparation.

　　Proficiency in use of common software applications including databases, regulatory applications, clinical computer systems, and word processing.

　　Preferred Qualifications

　　PhD in related discipline.

　　Minimum of one year of management experience.

　　Experience in writing protocols and informed consent documents, data analysis, grant writing, and manuscript preparation.

　　Proficiency in use of Redcap.

　　International clinical trial experience strongly preferred

　　Special Knowledge, Skills, & Abilities

　　Excellent organizational skills.

　　Excellent attention to detail.

　　Excellent ability to manage multiple and competing priorities.

　　Excellent time management skills, with demonstrated ability for self-direction and initiation.

　　Strong oral and written communication skills, and ability to work independently.

　　Demonstrated ability to work well with other professionals with minimal supervision and be comfortable being part of a diverse, international team.

　　Classified Title: Sr. Research Program Manager

　　Job Posting Title (Working Title): Sr. Research Program Manager, SMART4TB

　　Role/Level/Range: ACRP/04/ME

　　Starting Salary Range: Min $64,00 - Max $112,200 Annually ($88,100 targeted; Commensurate with experience)

　　Employee group: Full Time

　　Schedule: Monday-Friday, 8:30am-5:00pm

　　Exempt Status: Exempt

　　Location: Remote

　　Department name: SOM DOM Infectious Disease

　　Personnel area: School of Medicine

　　Total Rewards

　　The referenced salary range is based on Johns Hopkins University’s good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/

　　Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:

　　JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

　　**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

　　The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate’s conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

　　The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion (https://diversity.jhu.edu/roadmap-on-diversity-and-inclusion/) .

　　Accommodation Information

　　If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at [email protected] . For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu .

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　　The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.

　　The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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　　Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.