The Department of Neurology is seeking a Sr. Research Program Manager for the BIOS CTCC (Clinical Trials Coordinating Center) will support the innovative work of BIOS CTCC as a member of the BIOS project management team. BIOS manages multi-center, 30+ million dollar federally funded clinical trials and multiple site-specific pharmaceutical sponsored trials.
The Sr. Research Program Manager will work in collaboration with Division leadership and collaborating Principal Investigators and will set direction of projects within a large program with multiple study projects. The successful candidate will have overall managerial responsibilities for their individual project teams’ fiscal oversight for their assigned projects. The successful candidate will be expected to operate independently, with guidance provided by BIOS leadership. The candidate will have background and experience in research protection, federal and regulatory issues, research ethics, pharma law, pharmacovigilance, regulatory compliance, use of centralized IRBs and master agreements, and project management at the task level.
This position requires a high degree of independent action and adherence to strict timelines. Building and maintaining strong, trusting relationships is critical. The successful candidate will have experience presenting to investigative teams, end-users (faculty and staff), and subject-matter experts and must possess excellent negotiation, facilitation, consensus-building, and diplomacy skills and exhibit a strong helpline orientation. The successful candidate will be expected to stay current with a constantly changing clinical research technology and embrace the adoption of innovations to modernize, disseminate, renovate and remodel. This individual will serve as a knowledgeable liaison between the BIOS leadership and the research communities.
*This position reports to the BIOS Faculty and leadership.
Specific Duties & Responsibilities
- Will be involved in scientific discussions with collaborators, Principal Investigators, and funding organizations, and have authority to make independent decisions about research aims and study design.
- Provide support and guidance to research groups and assist Principal Investigators in submitting grant applications, IRB applications, and progress reports.
- Work with site investigators to help them meet targets and milestones (ensure timely and accurate submission to IRBs, sponsors and master agreements) and coordinate with the Project Director on site remediation, public outreach, public presentations, and web site development and content.
- Execute project management processes and methodologies to ensure projects are delivered on-time and within the budget, adhere to high quality standards, and benefit the investigative teams by ensuring smooth implementation of new trials from conception through study activation.
- Responsible for assembling project plans, team and work assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately.
- The Sr. Research Program Manager will also be responsible for managing investigator relationships.
- Responsible for tracking proposals and other documentation through signature/approval processes then through collaboration with Contracts personnel and IRB Navigators.
- Serve a critical role as liaison, facilitate meetings between project stakeholders and leadership, and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist in the auditing and monitoring of studies.
- Use professional judgment in handling information and be sensitive to project team, individual and all levels of organizational concerns; make use of data, statistical and quantitative analysis, explanatory and predictive modeling and fact-based management to drive decision making; and help investigators develop new insights and understanding of performance-based data.
Additional Knowledge, Skills & Abilities
- Knowledge of formal project management methodologies.
- Experience in a higher education environment.
- Will oversee and coordinate the work of teams in other institutions.
- Strong interpersonal and communication skills, both oral and written.
- Proficient in Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, and Teams.
- Proficient with SharePoint, collaborating and co-authoring of documents.
- Experience with REDCap preferred.
- Possess the ability to learn new software programs such as electronic data capture software and project management software, which will be taught on the job.
Minimum Qualifications- Master's degree or PhD in related discipline
- Eight years related experience including significant experience in field conducting large research projects
- Additional education may substitute for experience to the extent permitted by the JHU equivalency formula
Classified Title: Sr. Research Program Manager
Role/Level/Range: ACRP/04/ME
Starting Salary Range: $64,600 - $113,300 Annually ($89,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
Exempt Status: Exempt
Location: Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine
