MTA/DUA Study Start-up Program Manager (Office of Clinical Trials)

We are seeking a MTA/DUA Study Start-Up Program Manager who will be responsible for planning and directing the day-to-day operations, staffing, training, professional development, performance evaluation, and budgetary needs of the Johns Hopkins School of Medicine Office of Clinical Trials (OCT) commercial non-clinical research program, e.g., those conducted under material transfer and data use agreements (MTA/DUAs). The program is a centralized shared resource unit consisting of a team of assigned specialists dedicated to a portfolio of clinical divisions and their investigators working to facilitate start-up of commercially sponsored Material Transfer Agreements and Data Use Agreements. Start-up activities include coordination of internal partners (study teams, central research administrative teams) and external partners (commercial sponsors, CROs), coordination and initiation of contract activities, and initial applications to the IRB and other regulatory agencies. The manager is responsible for leadership, team building, strategic planning, process improvement, and management. Reporting to the Director of the OCT and in collaboration with other program stakeholders, will participate in developing, implementing, and evaluating existing and new initiatives to further the mission and goals of the program.

Specific Duties And Responsibilities

• Manage the day-to-day operations and staffing of the unit to streamline commercial MTA/DUA start-ups and maximize efficiencies while ensuring adherence to best practices, regulations/guidelines, and Standard Operating Procedures for human subjects protections and protocol integrity.
• Provide direction and coordination for Commercial MTA/DUA Program.
• Manage the end-to-end start-up process within the unit, from concept through activation.
• Supervise team of Commercial MTA/DUA regulatory specialists with activities including onboarding new clinical research operations personnel, performance evaluations, corrective actions, performance improvement plans, and career development.
• Facilitate effective teamwork among all involved personnel, e.g., regulatory specialists, research study teams, central research administrative personnel, etc.
• Partner and collaborate with the OCT Accelerated Study Start-up Program which is focused on commercial clinical trials.
• Provide support, guidance, and training to study teams to facilitate start-up of Commercial MTA/DUA including coordination and initiation of contract activities, initial applications to the IRB and other regulatory agencies, etc.
• Develop and implement systems for monitoring, reporting, and quality assurance activities.
• Communicate with and track activities led by internal and/or external research team members and collaborators.
• Monitor, track, and report critical study start-up milestones, e.g, IRB activities, processing and finalization of contracts, etc., Proactively manage and remove barriers to Commercial MTA/DUA project start-up.
• Liaison between study teams and central research administrative teams.
• Anticipate and mitigate risks to Commercial MTA/DUA project start-up.
• Develop and refine standard operating procedures for Commercial MTA/DUA project start-up activities.
• Collaborate with the Office of Research Administration in the coordination and initiation of contracts for new Commercial MTA/DUA projects.
• Contribute to meetings with program stakeholders and provide status updates and recommend changes to operations based on results and goals.
• Meet with institute- and department-based Research Council Chairs to address needs and concerns regarding new Commercial MTA/DUA project start-up, and communicate these needs, concerns, and action plans to the Director of OCT as appropriate.
• Represent the Commercial MTA/DUA Program on institute- and department-based Research Councils and other committees, tasks forces, and working groups as assigned or requested.
  
  

Minimum Qualifications

• Bachelor's Degree in a related field.
• Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
• Demonstrated knowledge and skills in accordance with Good Clinical Practice (GCP) guidelines, HIPAA, FDA regulations, and other federally mandated guidelines.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
  
  

Preferred Qualifications

• Master's Degree in related field.
• Certification as a Clinical Research Professional.
  
  

Classified Title: Study Start-up Program Manager

Job Posting Title (Working Title): MTA/DUA Study Start-up Program Manager (Office of Clinical Trials)

Role/Level/Range: ACRP/04/MD

Starting Salary Range: $55,800 - $97,600 Annually ($75,000 targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: M-F 8:30 am - 5 pm

FLSA Status: Exempt

Location: Hybrid/School of Medicine Campus

Department name: SOM Admin Res Clinical Research Contract

Personnel area: School of Medicine