Clinical Trial Project Manager

United States, Massachusetts, Somerville

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

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The General Hospital Corporation

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

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).

Does this position require Patient Care?

No

• 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.

Education

Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred

Can this role accept experience in lieu of a degree?

No

Licenses and Credentials

Experience

Progressively more responsible experience in a research related field 3-5 years required and Prior Supervisory Experience 1-2 years preferred

Knowledge,

Skills and Abilities

• 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.

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.

• 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…