Clinical Trial Project Manager I

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.

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.

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 and maintain positive relationships with researchers, clinicians, and funding agencies.

• Take on additional tasks and responsibilities as requested.

EDUCATION:

Bachelor's degree minimum requirement

EXPERIENCE:

Minimum of three years' experience working in project management or related field required.

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.

FISCAL RESPONSIBILITY:

The Clinical Trial Project Manager (Systems Use) will assist in study budget preparation and work with the grants management group to monitor study expenditures, as appropriate.

WORKING CONDITIONS:

This position will be performed in standard office conditions and can be either hybrid or remote. Must have reliable access to the internet. On occasion and at the discretion of the Director of Systems, the Clinical Trial Project Manager (Systems Use) may be required to be onsite for meetings, sponsor audits, or regulatory inspections. The position requires travel on public roads and air travel as needed. Advanced notice will be given.

Hybrid

399 Revolution Drive

40

Regular

Day (United States of America)

Pay Range

$63,252.80 - $102,596.00/Annual

Grade

7

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. 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. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

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 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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