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Job Summary
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 Assistant Project Manager will be responsible for assisting the Project Manager on providing oversight and leadership necessary for successful delivery of projects from initiation to implementation to close-out of assigned multi-center clinical research activities led by the NCRI. The Assistant Project Manager is expected to assist the Project Manager in effectively managing scope, schedule/timelines, budget, quality and resources of the assigned trial(s). The Assistant Project Manager will also assist the Project Manager in study management, include outside clinical site management, vendor management, and study meeting planning and execution.
Qualifications
Principal Duties and Responsibilities:
Collaborating with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment.
Developing study documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials and other study tools.
Working closely with Data Management, Systems and Biostatisticians to assist with the design of case report forms, study portals and electronic data capture systems.
Safety management and reporting to FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies and other regulatory bodies.
Leading cross-functional teams in the timely execution of high quality clinical research studies leveraging knowledge, expertise, and risk mitigation.
Building effective, high performance teams via expert communication, decisiveness, and technical expertise
Collecting, reviewing and approving of all required regulatory documents; and working to ensure the study Trial Master File (TMF) is up to date and “audit ready” throughout the course of the study.
Overseeing IND/CTA applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator held INDs/CTAs.
Assisting sites with IRB submissions, maintenance of regulatory documents and responding to study related questions from sites, vendors and sponsors in a timely fashion.
Scheduling and developing agendas and meeting minutes, in collaboration with the study team, for study related meeting – both remote and in person, and leading meetings/calls as needed.
Tabulating key metrics for progress reports, presentations, and assist in preparing publications.
Preparing materials including written summaries for internal and external communication (CT.gov, NEALS website, etc) and grant support (funding updates, progress reports, etc).
Reviewing monitoring plans and tracking and review of trip reports.
Working closely with Grants Management on study budget related questions and invoicing (site payments, vendor contracts, etc).
Working closely with PI/ Sponsor assist with management of vendor activities
Travel to national and international professional meetings as needed.
Escalating issues to Project Manager responsible for…