The program manager supports the larger function and initiatives of the NeuroPET Program (referred to as "the Program") at Ann Romney Center for Neurologic Diseases, Department of Neurology, under the supervision of the Director of the Program (referred to as "the Director") and ensures that short- and long-term objectives are fulfilled. The program manager will be responsible for all aspects of the Program including study development, execution, monitoring, and closeout, and ensure that reports and other deliverables are completed on time. The program manager will also be responsible for ensuring regulatory compliance and assisting with the preparation and submission of grant applications. The project manager will assess personnel needs and oversee the hiring and supervision of research staff. Ultimately, the program manager is responsible for providing strategic guidance and developing new infrastructure with increased efficiency to support a growing number of research projects in relation to NeuroPET imaging and research under the supervision of the Director.

Qualifications

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1. Operations Management:

- Assess potential projects and provides critical input regarding study feasibility.

- For new projects, document and facilitates the definition of project scope, goals, and resource requirements.

- Responsible for general study management; planning, execution, and evaluation of projects according to established timelines, procedures, guidelines, and budgets related to the project.

- Clearly and efficiently translates defined various projects' needs into deliverables, milestones, and timelines by establishing the project plan.

- Develops timelines, task lists, and operational plans for the completion of research projects, grant deliverables, and laboratory management goals in coordination with the Director.

- Responsible for study communications internally; virtual and in-person meetings concerning ongoing project aims, keeping meeting minutes and outlining action items, and ensuring study personnel (including project managers) are apprised of key decisions.

- Responsible for establishing and tracking major deliverables. Identifies roadblocks and alternative strategies for the completion of projects on-time and to specification and communicates updated information on at-risk deliverables or deadlines.

- Develops and implements patient recruitment strategies, in conjunction with the study team.

- Ensure timely and accurate projections and reporting.

- Monitor and track expenditures throughout the project, manage invoices and confirm revenue received, and analyze projections to ensure projects stay within budget.

- Identify and report accounting trends to the Director, highlighting any major variances and recommend changes if necessary.

- Ensure adherence to the study protocol and recommend mitigation strategies as necessary.

- Works closely with project leaders and project managers to establish quality criteria and monitor quality of projects.

- Create and maintain operational protocols for study conduct.

- Work closely with research staff to gain an understanding of data processing methods and tools.

- Develops, organizes, and/or maintains the study forms (CRFs).

- In conjunction with the study team, perform data validation and quality control, data entry into CRFs, if applicable. May be required to input data and do minimal analysis and run various reports.

- Maintain project databases, when applicable.

- Responsible for study staff training and certification where applicable.

- Maintain stakeholder engagement, provide updates as needed. Including but not limited to organizing patient communications and addressing study-related inquiries.

- Serve as liaison between the sponsor and institution to ensure all contracting details, billing arrangements, and overall milestone achievements are being observed.

- Maintain established regulatory requirements and coordinate with agencies as needed.

- Arrange and prepare for site monitoring visits and safety review board meetings.

- Organize any media and/or collaborator press and communications surrounding research accomplishments.

- Developing, proofing, and submitting abstracts and manuscripts resulting from study findings.

- Add value by creating new systems and processes for meeting the goals for various projects, budget management, reporting results and enabling the smooth function of projects, large and small, for all participants.

2. Research Compliance:

- Ensure that knowledge about regulatory requirements is current by reading and attending local seminars related to policy and regulatory issues (FDA, NIH, IRB, etc.)

- Maintain the Director and lab personnel documentation and certifications.

- Maintain proper agreements for all transfer and usage of data and materials (internally and externally).

- Develop and maintain new human subject research protocols (IRB).

- Prepare and submit necessary documents for amendments, other events, and continuing reviews of existing IRB protocols and monitor their status; follow through and oversee resolution of issues as needed.

- Ensure study personnel training and compliance documentation. Maintain established regulatory requirements and coordinate with agencies as needed.

- Create and maintain protocols safeguarding data and material sharing.

- Troubleshoot and manage data processing/sharing.

- Works with project managers and research assistants to perform data audits, including quality control and assurance of research data, as needed.

- Follow HIPAA guidelines and federal privacy protections for the management of patient privacy and study subject documentation.

- Establish material transfer and data use agreements as needed.

- Provides advice on regulatory documentation including IND/IDE applications, annual reports, adverse event reports, etc. to the appropriate regulatory agencies.

- Liaise with regulatory consultants regarding IND applications and ongoing FDA reporting.

3. Grants Management:

- Preparation and submission of grant applications, progress reports and final reports, including complex awards through to submission to funding agency.

- Maintain master documentation for the Director (i.e., biosketch, other support).

- Work in conjunction with Research Management for federal and non-profit entities on research agreements.

- Process new awards and establish deliverables with finance.

- Work in conjunction with the Clinical Trials Office for clinical research agreements with for-profit/industry sponsors, the Innovation office for non-clinical research agreements and material transfer with all parties, and Research Management for research agreements with federal and non-profit entities.

- Maintain institutional guidelines to ensure accurate pre-award execution.

- Ensure that any conditions outlined in the pre-award submission are consistent with the activities throughout the duration of the award.

- Work closely with research finance and the Director to create grant budgets and review progress throughout the course of a project.

- Periodic review of project funds outside of regular meetings, advise on changes and potential future expenses.

4. Administrative Management:

- Supervise team of project managers and research and/or administrative assistants to maintain effective workflow and meet the needs of the Program.

- As a member of the overall management team in Neurology Research, work with fellow program managers to develop and execute procedures throughout the department.

- Help develop and maintain working groups at the department level. Provide guidance and course correction when necessary with the Director's supervision and inputs.

- Train and assist project managers and research assistants in maintaining travel, expenses, and sponsored projects.

- Schedule and coordinate all conference and committee activities.

- Oversee the planning of seminars, social events, and meetings.

- Develop and maintain any external media, including NeuroPET Program website.

- In conjunction with the finance team, organize lab purchases including requisition submission, tracking, resolution of any ordering, receiving or other materials management-related issues, and follow-up to make sure issues are successfully resolved.

5. Personnel Supervision and Training:

- Assist the Director in assessing the needs of the program and make recommendations based on projected resources and upcoming projects.

- Generate job descriptions and advertisements.

- Assist in interviewing and hiring employees and sponsored staff.

- Participate in performance reviews and assist in generating areas for development across the team, at the direction of the Director.

- Provide ongoing education, particularly in the areas of research compliance, protocol activities, grant submissions, and general administration.

- Organize additional training opportunities considering institutional changes and/or observation of patterns amongst the team.

- Supervise project managers and research assistants, as it relates to ongoing studies.

QUALIFICATIONS:

• Bachelor's degree required; Master's degree in clinical or research operations preferred.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• 5+ years of related experience

• Experience in clinic management or research program management

• Experience in clinical research, preferred.

WORKING CONDITIONS:

• Hybrid work; remote and onsite. At least 50% onsite expected, subject to needs of the Program and Director discretion

• Some local, national, and international travel may be required.

• Risk of minimal exposure to ionizing radiation when in direct contact with research subjects injected with radioactive PET tracers.

EEO Statement

BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.