Clinical Trial Project Manager I

massgeneralbrigham; Somerville (MA); On-site; USD 85,000 - 115,000; Full time

Job summary

Mass General Brigham's Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital seeks a Project Manager to lead planning and management of clinical studies in collaboration with investigators and staff. This role reports to senior PM and supports day-to-day operations of assigned trials.

Responsibilities include coordinating across sites, ensuring regulatory compliance, and delivering study milestones within budgets. Travel to meetings may be required.

Qualifications

• Bachelor's degree in related field required; master's preferred.
• 3–5 years of experience in a research-related field.
• Prior supervisory experience is a plus.

Responsibilities

• Oversee startup, launch, conduct, and closeout of projects using NCRI platforms.
• Develop deadlines, budgets, and activities for projects.
• Collaborate with Data Management and PM teams on study portals and data capture systems.
• Ensure regulatory compliance for data platforms used in clinical research.
• Lead startup and conduct of multi-center clinical research projects.
• Prepare periodic reports for sponsors and regulatory agencies.
• Travel to national and international meetings as needed.

Skills

Strong organizational skills

Strong communication skills

Analytical skills

Budget management

Staff supervision

Database management

Education

Bachelor's degree in related field

Master's degree related field preferred

Tools

SAS

Data management systems

EDC systems

Job description

Site: 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.

Job Summary

Summary

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

Essential Functions

• 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.

Qualifications

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

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.

Additional Job Details (if applicable)

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.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Relevant activities include, but are not limited to, the following:

• 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