Clinical Trial Assistant Project Manager

Massachusetts General Hospital; Somerville (MA); Hybrid; USD 63,000 - 103,000; Full time

Job summary

Mass General Brigham's Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital is seeking an Assistant Project Manager to support multi-center clinical trials in neurology. You will help manage scope, timelines, budget and study coordination under the PM team.

This role involves cross-functional collaboration with investigators, sites, data managers and vendors, with travel to national/international meetings and a hybrid work arrangement from the Somerville area.

Qualifications

• Bachelor's degree required.
• 1 year of experience in research or related field required; 2-3 years preferred.
• Biology or scientific background preferred but not required.
• Knowledge of federal regulations relating to protection of human subjects and good clinical practice guidelines.

Responsibilities

• Collaborate with investigators and sites to meet startup, activation, recruitment targets.
• Develop protocol, consent forms, manuals, and recruitment materials.
• Work with data management and biostatisticians to design case report forms and electronic data capture systems.
• Safety management and regulatory reporting to FDA and other bodies.
• Lead cross-functional teams to execute high-quality clinical research studies on time.
• Build high-performance teams through communication and expertise.
• Manage regulatory documents and ensure TMF is audit-ready.
• Oversee IND/CTA submissions and regulator communications.
• Assist sites with IRB submissions and regulatory questions.
• Schedule and prepare meeting agendas/minutes, remote and in-person.
• Tabulate progress metrics for reports and publications.
• Prepare internal/external communications and grant updates.
• Review monitoring plans and trip reports.
• Coordinate with Grants Management on budgets and invoicing.
• Coordinate with PI/Sponsor on vendor management.
• Travel to national and international meetings as needed.
• Escalate issues to Project Manager and take on extra tasks.

Skills

Regulatory knowledge

Attention to detail

Organizational skills

Analytical skills

Team collaboration

Communication

Education

Bachelor's degree

Tools

Microsoft Office

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

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.

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 assigned projects, as appropriate.
• Taking on additional tasks and responsibilities, as requested.

Qualifications

• A bachelor's degree is required.
• At least one year of experience in research or a related field required; previous industry clinical trial experience 2-3 years preferred.
• Background/familiarity with biology or other scientific discipline is preferred but not required.

Skills/Abilities/Competencies Required

• Knowledge of federal regulations relating to protection of human subjects and good clinical practice guidelines.
• Attention to detail, excellent organizational and analytical skills.
• Excellent computer skills working with Microsoft Office.
• Team player who can take direction to work independently in an extremely fast moving, deadline-driven environment, while balancing multiple tasks simultaneously.

Additional Job Details (if Applicable)

Remote Type

Hybrid

Work Location

399 Revolution Drive

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$63,252.80 - $102,596.00/Annual

Grade

7

In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth.

EEO Statement

1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.