Clinical Research Program/Project Manager

GENERAL SUMMARY/ OVERVIEW STATEMENT:

Functions independently as Clinical Research Program/Project Manager for the Harvard Aging Brain study and other affiliated studies at Massachusetts General Hospital, Brigham and Women's Hospital, and Harvard Medical School. The team works across MGH and BWH to better understand the changes in the brain that may lead to Alzheimer's disease, and to investigate novel preventative treatments.

The Clinical Research Program/Project Manager is responsible for all operational components related to study initiating, planning, execution, monitoring/controlling, and closeout. Reporting to the Program Director and working with several Principal Investigators across MGH and BWH, the Clinical Research Program/Project Manager will oversee recruitment of elderly of cognitive impaired participants for clinical trials, imaging, and other research projects. Will assist the Program Director and Principal Investigators with administrative oversight, including regulatory and financial aspects of a large and growing portfolio of projects. This position will also interface and liaise with the Massachusetts Alzheimer's Disease Research Center (MADRC). The Clinical Research Program/Project Manager is expected to effectively manage scope, schedule/timelines, budget, quality and resources of the Harvard Aging Brain Study, and affiliated trials. The Clinical Research Program/Project Manager will work with other project managers to develop new infrastructure to increase the volume and efficiency of current and future research projects.

Drawing on an understanding of department operations and previous experience working with multidisciplinary clinical and/or technical teams as well as displaying a high degree of initiative and independent judgment, the incumbent must exhibit exceptional interpersonal skills in order to collaborate closely with departmental leadership and staff at all levels to lead efforts mentioned above. Requires discretion and judgment to organize priorities, complete tasks and handle sensitive patient information.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Operations Management

* Responsible for all aspects of project direction and study coordination for numerous NIH funded studies (~$50 million), including the Harvard Aging Brain Study. Also includes oversight and management of new pilot projects affiliated with the Harvard Aging Brain Study. Specific responsibilities include (but are not limited to):
* Contributing to protocol development and design
* Supervises the preparation of all documentation for securing IRB approval, and then ensuring on-going IRB approval for the study and study sites.
* Develops and implements operational procedures for studies to logically and effectively sequence and structure the protocol-required study procedures as part of responsibility for all aspects of study direction and administration.
* Synchronizing recruitment efforts across studies
* Determining personnel needs & hiring additional staff as required
* Managing imaging and clinical assessment schedules
* Monitor study progress to ensure milestones are met
* Responsible for the oversight of data collection, data entry, and data quality assurance
* Ensures ongoing data integrity by working closely with data management/informatics for quality control of data. Oversees development and amends standard manual of operating procedures and study protocol documents.
* Manages scope, schedule/timelines, budget, quality and resources of the assigned trial(s) to meet all projects and program needs.
* Ensure program has adequate administrative support.
* Monitor and control study progress, ensuring timelines are met, and corrective action is implemented when appropriate.
* Provide feedback on project and program initiatives, influencing roadmap for future projects

Personnel & Communications Management

* Oversees hiring, evaluation, discipline, firing, training and orientation of a staff; serve as direct supervisor for MGH clinical research coordinators, admins, and part-time staff.
* Oversight of personnel requirements, including schedules of >50 investigators, professional and research staff for research meetings and participant assessments
* Lead team discussions to drive decision making and resolve action items.
* Communicate clearly and strategically within a distributed team environment, leverage the best tools available to effectively facilitate the conversation.
* Identify, problem-solve and communicate with the Program Director on any issues that interfere with project deadlines, project scope, team or project goals.

Program Management

* Lead initiatives to promote collaboration and inclusion program-wide (MGH & BWH), following guidance from senior leadership
* Works closely with Project Managers at MGH and BWH to seamlessly integrate R01 protocols across sites, including clinical measures, data management, and imaging.
* Contributes to the content and development of numerous data forms and documents for multiple trials and research studies.
* Lead projects forward with a spirit of progress and by example, establishing self as a critical role in progress.
* Responsible as a key contact for project-related information and for obtaining and maintaining a comprehensive knowledge of the program scope, deliverables, timelines, status and key risks and mitigation strategies.
* Represent the study group at meetings and conferences, as applicable
* Works as an autonomous decision maker but recognizes when the involvement of the Program Director or other stakeholders is required.
* Evaluating how changes may impact the organization's operations and awareness of implications on a variety of teams. Supports operational improvement initiatives, in partnership with clinical and administrative leadership as appropriate. Goals for this work will often relate to improvement in operational efficiency, high performance team dynamics, capacity management, quality and safety.
* Responsible for management and maintenance of program-wide clinical trial management system (CTMS), including QA, access and permissions, and liaising with the vendor to ensure proper function and regulatory compliance.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

* Must be able to make independent, effective and appropriate decisions in numerous situations
* Excellent judgment and ability to understand, interpret and implement protocol requirements
* Excellent organizational skills to formulate long term complex procedure requirements in compliance with vigorous and competing timetables
* Strong interpersonal, leadership and team-building skills and the ability to smoothly integrate the demands of sponsors, hospital and other groups necessary to perform all aspects of multiple clinical trials being run concurrently
* Demonstrated knowledge of clinical research involving IRB and NIH regulatory responsibilities.
* Requires a high level of discretion, as some studies involve highly sensitive and private information.
* Ability to interact with professionals at multiple levels including NIH and industry leaders.
* Ability to make independent and effective decisions, to interpret information and protocol requirements.
* Ability to track and oversee multiple aspects of ongoing and new projects, including staffing needs, recruitment goals, and financial expenditures,
* Strong interpersonal skills and the ability to oversee the work of research assistants.
* Excellent written and verbal skills.
* Ability to oversee the work of research assistants.

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS:

Project Management Professional (PMP) certification strongly preferred but not required.

EDUCATION:

B.A., B.S. required with background in psychology, neuroscience, or premedical preferred. Master's degree or other advanced degree strongly considered.

EXPERIENCE:

Minimum of 5 years' progressively more responsible experience in a clinical research setting required. Previous organizational/project managerial experience in clinical research is required. Previous experience with administrative/regulatory requirements for research (IRB, NIH, FDA reports) required. Basic medical and pharmacological knowledge required. Experience with elderly and cognitively impaired subjects preferred.

SUPERVISORY RESPONSIBILITY:

Oversight of clinical research coordinators, research assistants, admins, and student volunteers (8-10 FTE).

FISCAL RESPONSIBILITY:

* Tracking expenditures on imaging components of research protocols, including PET and MRI studies
* Work with study PIs, Grants Administrators, and Program Director to coordinate salary distributions for faculty and staff.

WORKING CONDITIONS:

* Office and clinic environment. Option to work remotely some days.
* Must be able to travel between hospital and research buildings carrying and securing study documents and materials.