Research Program Manager

3 weeks ago

Baltimore, United States Johns Hopkins University Full time

The Department of Neurology is seeking a **_Research Program Manager_** who will deliver and organize work plans with 20+ clinical sites across the country in support of clinical trial research goals of the BIOS Clinical Trials Coordinating Center's (CTCC). Activities include training and managing clinical and data entry personnel at numerous collaborating

centers in regard to specified trial cycle metrics, protocol fidelity, and oversight of local, institutional and federally required regulatory compliance across the network of collaborators.

**Specific Duties & Responsibilities**
- Establish early lines of communication with the clinical teams as they are selected and prepared for activation.
- Assist with site evaluations detailing the availability of critical local resources necessary to be successful at enrollment and protocol performance once the trial begins.
- Conduct monthly (or more frequent) teleconferences with the clinical teams and individually mentor new coordinators.
- Keep enrollments on track with established performance expectations.
- 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.
- Will assemble project plans, team and work assignments, directing and monitoring work efforts daily, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately.
- Manage investigator relationships.
- Track proposals and other documentation through signature/approval processes then through collaboration with Contracts personnel and IRB Navigators.
- 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.
- Handle 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**
- Advanced knowledge and experience with GCP/ICH and local regulations.
- 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.
- 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, eIRB, and project management software, which will be taught on the job.
- Excellent leadership skills with ability to negotiate and work collaboratively.
- Service-oriented with excellent verbal and written communication and organization skills.

**Minimum Qualifications**
- Bachelor's Degree in related discipline.
- Five years related experience, including demonstrated supervisory or lead responsibilities.
- Project/system process lifecycle experience
- Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

**Preferred Qualifications**
- Master's Degree preferred.
- Knowledge of formal project management methodologies
- Minimum of 2 years of direct project management.
- Experience in a higher education of academic medicine environment.
- Knowledge and experience with GCP/ICH and local regulations.

Classified Title: Research Program Manager
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,200 - $96,600 Annually ($75,900 targeted; Commensurate with experience)
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

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