Research Program Manager
The Department of Neurology is seeking a Research Program Manager (RPM) who will develop work plans to achieve assigned project goals and organize activities with collaborative sites in support of project goals. This includes training and managing collaborative site personnel and other trial site personnel regarding fidelity of protocols and data collection for the specific assigned process metrics used in the trial under management.
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.
Ability to make independent judgments and to act on decisions on a daily basis. 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. Will oversee and coordinate the work of teams in other institutions. Ability to maintain confidentiality. Strong interpersonal and communication skills, both oral and written.
This position reports to the BIOS Faculty and leadership.
Specific Duties & Responsibilities:
Minimum Qualifications (Mandatory):
- The RPM will have the critically-important responsibility for establishing early lines of communication with the clinical teams as they are selected and prepared for activation.
- The RPM will be integral to propel the subject accrual and monthly goals of enrollments per month across all sites.
- They will ssist with site evaluations detailing the availability of critical local resources necessary to be successful at enrollment and protocol performance once the trial begins.
- They will assist sites in central IRB on-boarding, ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
- During trial implementation, the RPM will oversee site performance, assist with subject eligibility and randomization, identify local 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.
- Will conduct monthly (or more frequent) teleconferences with the clinical teams and individually mentor new coordinators.
- The RPM is critical to keeping enrollments on track with established performance expectations.
- The RPM will also provide support for quality assurance monitors in all facets of work related to communications with and management of the enrolling center clinical teams.
- 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 RPM 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.
- Will serve a critical role as liaison and 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.
- Will 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.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience. 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.Preferred Qualifications:
- Bachelor Degree required.
- Minimum of five (5) years' experience in delivering effective project management solutions.
- Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
- Master's Degree in a relevant field preferred.
- Project/system process lifecycle experience, including 2+ years of direct project management.
* 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.Special Knowledge, Skills & Abilities:
- Understands and can apply knowledge of clinical trial designs to trial execution.
- Advanced knowledge and experience with GCP/ICH and local regulations.
- Experience in web-based data collection applications.
- Ability to prioritize own work and work of others as needed.
- Strong organizational skills, analytical and problem solving abilities, and attention to detail.
- Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines.
- 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; experience in a higher education environment.
Classified Title: Research Program Manager
Starting Salary Range: $53,020 - $72,930 annually (commensurate with experience)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: SOM Neuro BIOS
Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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 HR Business Services Office at firstname.lastname@example.org
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Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/
and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/
.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.Equal Opportunity Employer
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Learn more:https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdfTo apply, visit https://jobs.jhu.edu/job/Baltimore-Research-Program-Manager-MD-21202/823054000/
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