Clinical Trial Project Manager

The Neurological Clinical Research Institute (NCRI), at the Massachusetts General Hospital (MGH) is a premier Academic Clinical Research Organization (CRO) managing Clinical Trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, Project Managers, data managers, SAS programmers, systems analysts, grants managers, and administrative assistants dedicated to planning and implementing Clinical Trials.
Reporting to a senior member of the PM team, the Project Manager will be responsible for providing oversight and leadership necessary for the successful delivery of projects from initiation to implementation to close-out of assigned multi-center clinical research activities led by the NCRI. The Project Manager is expected to effectively manage the scope, schedule/timelines, budget, quality, and resources of the assigned trial(s). Study management will also include outside clinical site management, vendor management, and study meeting planning and execution.

Primary Responsibility for the following assigned studies:
Collaborate with project investigators and research sites to ensure targets are met for study start-up, site activation, patient recruitment, and enrollment.
Develop/contribute to clinical documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials, and other study tools.
Work closely with Data Management, Systems, and Biostatisticians to assist with the design of case report forms, study portals, and electronic data capture systems.
Assist in safety management and reporting to the FDA, Data and Safety Monitoring Boards, medical monitors, funding agencies, and other regulatory bodies.
Lead cross-functional teams in the timely execution of high-quality clinical research projects leveraging knowledge, expertise, and risk mitigation while functioning as the principal liaison with key clients, vendors, and internal team members.
Build effective, high-performance teams via expert communication, decisiveness, and technical expertise.
Collect, review, and approve all required regulatory documents; and work to ensure the study Trial Master File (TMF) is up to date and "audit ready" throughout the course of the study.
Oversee IND/CTA applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator-held INDs/CTAs
Assist project sites with IRB submissions, maintenance of regulatory documents, and responding to study-related questions from sites, vendors, and sponsors in a timely fashion.
Schedule and develop agendas for project meetings and conference calls.
Tabulate key metrics for progress reports, help develop presentations for scientific meetings, and assist in preparing publications.
Prepare presentation materials, such as slide decks, that summarize study progress and efficiency metrics.
Plan, manage, execute, and participate in all study team meetings both remote and in person.
Work closely with PI/ Sponsor to assist with the management of vendor activities
Travel to national and international professional meetings as needed.
Prepare materials including written summaries for internal and external communication (CT.gov, NEALS website, etc) and grant support (funding updates, progress reports, etc).
Job Description 2
Review monitoring plans and tracking and review of trip reports.
Work closely with Grants Management on study budget-related questions and invoicing (site payments, vendor contracts, etc).

Take on additional tasks and responsibilities, as requested.

A bachelor's degree is required.
Minimum of three years experience working in project management related to clinical research, academic research, or similar environment required.
Background/familiarity with biology or other scientific discipline is preferred, but not required.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

Ability to design, prepare, deliver, and evaluate multicenter clinical studies.
High level of time management and organizational skills
Excellent written and verbal communication skills
Administrative skills to meet regulatory requirements
Ability to prepare and monitor study budgets
A solid understanding of clinical research methodology and regulations.
Sound interpersonal skills and the ability to mentor/supervise others.
Ability to identify problems and develop potential solutions.
Experience writing and submitting IRB protocols and knowledge of regulatory processes and regulations is preferred, but not required.
Excellent computer skills working with Microsoft Office.
Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.

WORKING CONDITIONS:

This role has established a long-term and sustainable, structured, flexible workplace program that allows both in-office and off-site work. In-office is standard office conditions. An employee's primary residence is expected during working days for off-site work and must comply with institutional confidentiality requirements. There may be travel on public roads and air travel as needed.

SUPERVISORY RESPONSIBILITIES:

Ability to train, and provide oversight & mentoring of Clinical Trial assistant Project Manager(s) and staff assistants, as appropriate.

FISCAL RESPONSIBILITY:

Clinical Trial Project Manager will assist in study budget preparation and work with the grants management group to monitor study related expenditures, as appropriate.