Clinical Trial Project Manager 1

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 Project Manager will be responsible for 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 Project Manager is expected to effectively manage scope, schedule/timelines, budget, quality and resources of the assigned trial(s). Study management will also include outside clinical site management, vendor management, and study meeting planning and execution.

Qualifications

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Primary Responsibility for the following on assigned studies:

• Collaborate with project investigators and research sites to ensure targets are met for study start-up, site activation, patient recruitment, and enrollment.
• Develop/contribute to clinical documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials, and other study tools.
• Work closely with Data Management, Systems, and Biostatisticians to assist with the design of case report forms, study portals, and electronic data capture systems.
• Assist in safety management and reporting to the FDA, Data and Safety Monitoring Boards, medical monitors, funding agencies, and other regulatory bodies.
• Lead cross-functional teams in the timely execution of high-quality clinical research projects, leveraging knowledge, expertise, and risk mitigation while functioning as the principal liaison with key clients, vendors, and internal team members.
• Build effective, high-performance teams via expert communication, decisiveness, and technical expertise.
• Collect, review, and approve of all required regulatory documents; and work to ensure the study Trial Master File (TMF) is up to date and "audit ready" throughout the course of the study.
• Oversee IND/CTA applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator-held INDs/CTAs
• Assist project sites with IRB submissions, maintenance of regulatory documents, and responding to study-related questions from sites, vendors, and sponsors in a timely fashion.
• Schedule and develop agendas for project meetings and conference calls.
• Tabulate key metrics for progress reports, help develop presentations for scientific meetings, and assist in preparing publications.
• Prepare presentation materials, such as slide decks, that summarize study progress and efficiency metrics.
• Plan, manage, execute, and participate in all study team meetings, both remote and in person.
• Work closely with the PI/ Sponsor, assist with the management of vendor activities
• Travel to national and international professional meetings as needed.
• Prepare materials including written summaries for internal and external communication (CT.gov, NEALS website, etc) and grant support (funding updates, progress reports, etc).
• Work closely with Grants Management on study budget-related questions and invoicing (site payments, vendor contracts, etc).
• Take on additional tasks and responsibilities, as requested.

QUALIFICATIONS:

• A bachelor's degree is required.
• Minimum of three years of experience working in project management related to clinical research, academic research, or a similar environment required.
• Background/familiarity with biology or other scientific disciplines is preferred, but not required.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Ability to design, prepare, deliver, and evaluate multicenter clinical studies.
• High level of time management and organizational skills
• Excellent written and verbal communication skills
• Administrative skills to meet regulatory requirements
• Ability to prepare and monitor study budgets
• A solid understanding of clinical research methodology and regulations.
• Sound interpersonal skills and the ability to mentor/supervise others.
• Ability to identify problems and develop potential solutions.
• Experience writing and submitting IRB protocols and knowledge of regulatory processes and regulations is preferred, but not required.
• Excellent computer skills working with Microsoft Office.
• Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.

WORKING CONDITIONS:

• Standard Office conditions.
• Will travel on public roads and air travel as needed.

SUPERVISORY RESPONSIBILITY:

Ability to train and provide oversight & mentoring of clinical trial assistant project manager(s) and staff assistants, as appropriate

Additional Job Details (if applicable)

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
• Carrying Frequently (34-66%) 20lbs- 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision- Far Constantly (67-100%)
• Vision- Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

Remote Type

Hybrid

Work Location

399 Revolution Drive

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

EEO Statement:

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 Veteran's 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.

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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.