Johns Hopkins University
Sr. Research Program Manager
Johns Hopkins University, Baltimore, Maryland, United States, 21276
The Department of Neurology is seeking a
Sr. Research Program Manager
for the BIOS CTCC (Clinical Trials Coordinating Center) who 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 role involves overseeing and coordinating the work of teams in other institutions and having overall managerial responsibilities for their individual project teams and fiscal oversight for their assigned projects. 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 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
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. Manage investigator relationships. Responsible for tracking proposals and other documentation through signature/approval processes then through collaboration with Contracts personnel and IRB Navigators. Serve as a critical 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 and Abilities
Excellent leadership skills with ability to negotiate and work collaboratively. Service-oriented with excellent verbal and written communication and organization skills. Knowledge of formal project management methodologies. Ability to make independent judgments and act on decisions daily. Ability to work for long periods of time without direction. Ability to prioritize own work and work of others as needed. Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines. Very strong organizational skills, analytical and problem-solving abilities, and attention to detail. Demonstrated ability to coordinate projects independently and work constructively as part of a team. Ability to maintain confidentiality. 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. 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 in Health-related Sciences or Related Discipline. Eight years related experience in clinical research, including experience with 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. Additional education may substitute for experience to the extent permitted by the JHU equivalency formula. Preferred Qualifications
PhD preferred. Experience with REDCap preferred. Experience in a higher education environment. Classified Title: Sr. Research Program Manager Role/Level/Range: ACRP/04/ME Starting Salary Range: $64,600 - $113,300 Annually (Commensurate with experience) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: Hybrid/School of Medicine Campus Department name: SOM Neuro BIOS Personnel area: School of Medicine
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Sr. Research Program Manager
for the BIOS CTCC (Clinical Trials Coordinating Center) who 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 role involves overseeing and coordinating the work of teams in other institutions and having overall managerial responsibilities for their individual project teams and fiscal oversight for their assigned projects. 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 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
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. Manage investigator relationships. Responsible for tracking proposals and other documentation through signature/approval processes then through collaboration with Contracts personnel and IRB Navigators. Serve as a critical 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 and Abilities
Excellent leadership skills with ability to negotiate and work collaboratively. Service-oriented with excellent verbal and written communication and organization skills. Knowledge of formal project management methodologies. Ability to make independent judgments and act on decisions daily. Ability to work for long periods of time without direction. Ability to prioritize own work and work of others as needed. Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines. Very strong organizational skills, analytical and problem-solving abilities, and attention to detail. Demonstrated ability to coordinate projects independently and work constructively as part of a team. Ability to maintain confidentiality. 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. 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 in Health-related Sciences or Related Discipline. Eight years related experience in clinical research, including experience with 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. Additional education may substitute for experience to the extent permitted by the JHU equivalency formula. Preferred Qualifications
PhD preferred. Experience with REDCap preferred. Experience in a higher education environment. Classified Title: Sr. Research Program Manager Role/Level/Range: ACRP/04/ME Starting Salary Range: $64,600 - $113,300 Annually (Commensurate with experience) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: Hybrid/School of Medicine Campus Department name: SOM Neuro BIOS Personnel area: School of Medicine
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