Clinical Trial Project Manager 1
Clinical Trial Project Manager 1
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1 Vacancy
Job Description
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 ( 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 bachelors 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
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
EEO Statement:
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.
Required Experience:
IC
Employment Type
Full-Time
