The Sr. Research Program Manager, in collaboration with the study Principal Investigators (PIs), will serve as Manager for a large sponsor-funded, multi-site clinical trial in the Johns Hopkins Multiple Sclerosis (MS) Precision Medicine Center of Excellence that is within the Division of Neuroimmunology & Neurological Infections, Department of Neurology.
The Sr. Research Program Manager will oversee all operations for the clinical trial and will serve as a resource for participating sites regarding the study protocol and trial logistics in conjunction with the Project Manager (a Research Program Manager), whom the Sr. Research Program Manager will supervise. S/he will be responsible for monitoring enrollment and retention and helping with onboarding new study team members at Johns Hopkins and at participating sites. S/he will also assist and/or oversee the monitoring of site budgets (estimated 45 sites) and invoicing process, monitoring of the data (along with other study team monitors), and generating reports for the Study Advisory Committee (SAC) and Data and Safety Monitoring Board (DSMB) meetings. Additionally, s/he will be responsible for updating the clinicaltrials.gov site as appropriate, monitoring and managing the regulatory process and subcontracts, and backing up the Project Manager and statistician as needed. Specific duties & responsibilities:
Minimum qualifications (mandatory):
- Be involved in scientific discussions with collaborators, PIs, and funding organizations, and have authority to make independent decisions about trial conduct and troubleshooting.
- Manage research staff members (recruitment, performance appraisal, feedback, discipline concerns, separations).
- Identify recruitment problems, personalize remediation programs with site teams, and help to assure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion. Help meet with site teams and mentor new coordinators.
- Collaborate with Research Program Manager in the preparation and tracking of financial documents, such as activity budgets and related documents.
- Maintain proficiency in policies, procedures, and best practices in research data collection and management.
- Help manage data access permissions for site personnel.
- Develop and modify research instruments (e.g., protocol specific source documentation) necessary for study.
- Develop data management solutions using programming and analytical expertise for this multi-site clinical trial.
- Help monitor the study for data quality and completeness using tables, figures, and listings to identify potential data quality issues and track their resolution with site personnel
- Coordinate and present at project meetings and conference calls, including scheduling, agendas, notes, and follow up on action items.
- Prepare materials for reports and manuscripts.
- Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
- Participate in other research initiatives as workload allows.
- Master's degree or PhD in related discipline required.
- Eight (8) years related experience delivering effective project management solutions including significant experience in field conducting large research projects required.
- Extensive experience with clinical research sciences, regulatory affairs.
- Extensive experience with protocol and informed consent writing, grant writing, and manuscript preparation and production.
- Prior experience managing clinical research staff required.
- Comfortable working in a fast-paced environment and be proactively responsible and accountable to define and confirm work, and to effectively prioritize managing multiple tasks while setting and meeting self-set and agreed upon deadlines. Proven ability to establish realistic goals and deliver work on schedule.
- Strong personnel management and communication skills.
- Strong knowledge about issues in human subjects research, data management and security, reproducible research practices.
- Experience in creating and maintaining data collection instruments, designing and maintaining projects, and creating reports using REDCap or other electronic data capture systems.
- Good interpersonal skills for communicating with colleagues across various disciplines, attention to detail, critical thinking and problem-solving abilities, and the ability to manage multiple competing priorities.
- Ability to solve problems as they arise and communicate effectively with staff, colleagues and PIs/Director.
- Advanced knowledge and experience with ICH/GCP; experience working with JHU/ local regulations is a plus.
Classified Title: Sr. Research Program Manager
Working Title: Sr. Research Program Manager
Starting Salary Range: commensurate with experience
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10003522-SOM Neuro Neuroimmunology
Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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