Clinical Trial Project Manager I

Mass General Brigham•Somerville, MA

1d•$63,253 - $102,596•Hybrid

About The Position

The position reports directly to the Sr Project Manager and/or Project Director of a large global clinical study. This position has management responsibility for specific roles within a clinical study assigned to support the day-to-day operational project management of assigned trial(s). The Neurological Clinical Research Institute (NCRI), at the Massachusetts General Hospital (MGH) is a premier Academic Research Organization (ARO) managing clinical trials in neurological disorders. The NCRI employs physician clinical researchers, research nurses, project managers, data managers, SAS programmers, systems analysts, grants managers, research nurses, quality specialists and administrative assistants dedicated to planning and implementing clinical trials. Reporting to a senior member of the Systems team, the Project Manager is responsible for planning, leading, managing, and supporting clinical projects and data analytical/data sharing activities for inter-connected disease-specific clinical research consortia, individual investigators, and biotech companies. The Systems PM will work closely with sponsors, clinicians, investigators, project and data managers, study monitors, and biostatistical groups.

Requirements

Bachelor's Degree Related Field of Study required
Progressively more responsible experience in a research related field 3-5 years required
Strong organizational and communication skills.
Demonstrated analytical skills.
Effective problem solving skills.
Ability to supervise and train staff effectively.
Strong database management and computer skills.
Must possess aptitude for budget management.
Bachelor's degree minimum requirement
Minimum of three years' experience working in project management or related field required.

Nice To Haves

Master's Degree Related Field of Study preferred
Prior Supervisory Experience 1-2 years preferred
Experience related to clinical research, academic research, or similar environment preferred.
Experience related to data management, platforms, and software tools utilized in clinical research, such as Electronic Data Capture and Clinical Trials Management Systems is preferred.
Background/familiarity with biology or other scientific disciplines is preferred but not required.

Responsibilities

Collaborating with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment.
Safety management and reporting to FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies and other regulatory bodies.
Collecting, reviewing and approving of all required regulatory documents; and working to ensure the study Trial.
Managing multi-center trials funded by NIH, Industry standards.
Collaborate with grants management team to prepare progress reports.
Provide safety management oversight for studies, in collaboration with study PI and safety boards.
Oversee all activities necessary to plan, launch, conduct, and close out the individual projects that utilize NCRI platforms for clinical research.
Develop and control deadlines, budgets, and activities for individual projects while maintaining smooth operation of the overall program.
Work closely with Data Management, Project Management, and other cross-functional teams to oversee the design of study portals and electronic data capture systems.
Ensure projects’ compliance with regulatory and procedural requirements for data platforms used in clinical research.
Lead in all aspects of startup and conduct of simultaneous inter-connected multi-center clinical research projects
Build effective, high-performance teams via expert communication, decisiveness, and technical expertise.
Schedule and develop agendas for project meetings and conference calls.
Prepare presentation materials, such as slide decks, that summarize study progress and efficiency metrics.
Create materials including Standard Operating Procedures, User Manuals, Case Report Forms, study tools and templates.
Prepare periodic reports for sponsors, funding agencies and regulatory agencies, as required.
Develop and enforce data sharing and publication policies.
Develop, maintain, and enforce the language utilized in research protocols, grant proposals, data use agreements, and consent forms.
Plan, manage, execute and participate in all study team meetings both remote and in person.
Travel to national and international professional meetings as needed.
Work closely with Grants Management on study budget-related questions and invoicing (site payments, vendor contracts, etc.).
Develop and maintain positive relationships with researchers, clinicians, and funding agencies.
Take on additional tasks and responsibilities as requested.
Assist in study budget preparation and work with the grants management group to monitor study expenditures, as appropriate.