Clinical Trial Project Manager

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.

 

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 the 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.

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 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 to 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).
• Review monitoring plans and tracking, and review of trip reports.
• 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:
This role has established a long-term and sustainable, structured, flexible workplace program that allows both in-office and off-site work. In-office is standard office conditions. An employee’s primary residence is expected during working days for off-site work and must comply with institutional confidentiality requirements. There may be 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.

FISCAL RESPONSIBILITY:
The Clinical Trial Project Manager will assist in study budget preparation and work with the grants management group to monitor study-related expenditures, as appropriate.

 

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.

 

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%)

 

Hybrid