Clinical Research Project Manager, MGB Office of Clinical Research CCI
Boston, NH - USA
Job Summary
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
We are seeking an intellectually curious and highly organized individual with clinical trial interest/experience to serve as a Project Manager in the Center for Clinical Investigation (CCI) which is a part of the MGB Office of Clinical Research (OCR). The candidate will work with the Research Operations Director Department Managers and Principal Investigators.The mission of the MGB OCR CCI is to strengthen the culture for clinical research at the Brigham and Womens Hospital by building services helpful to clinical investigators and facilitating the success of individual investigators.
Qualifications
The MGB OCR CCI Project Manager will be responsible for developing and maintaining the infrastructure of research studies and clinical trial by supporting the design planning and management of the projects.
Principal Duties and Responsibilities:
Provides strong leadership as a liaison between the investigators sites and sponsors. This includes:
- Developing a plan for all projects and ensuring follow-up on all discussions and requesting an update on projects.
- Meeting with the research team regularly to review trial projects timelines and action items
- Manage regulatory compliance and sponsor study start-up activities
- Foster a team environment
- Lead additional special project oversight as requested
Operational Management
Develop and maintain the infrastructure of studies and clinical trials by supporting the design planning and management activities including the following:
Regulatory
Submit IRB Applications and required reporting including commercial IRB submissions and cede review applications
Manage site regulatory documents and binders
Manage postings
Study documents
Assist in preparation of protocol and informed consent forms
Assist with recruitment materials
Oversee preparation and maintenance of Manuals of Procedures
Oversee site and staff training materials
Manage study portal and access to study documents and trial materials
Education
Bachelors Degree Related Field of Study required or Masters Degree Related Field of Study preferred
Can this role accept experience in lieu of a degree
No
Licenses and Credentials
Experience
- At least 2-3 years of senior clinical research coordinator or project management clinical research experience
- High proficiency withMicrosoft Office particularly with Excel
Knowledge Skills and Abilities
Outstanding organizational skills are necessary to manage detailed information and priorities across competing timetables and responsibilities. Ability to plan for the timely and successful completion of short- and long-term objectives.
Excellent verbal and written communication skills to communicate effectively with a large and diverse constituency including senior hospital leaders division faculty and support staff representatives of other BWH offices collaborating institution officials granting agencies (NIH industry and foundations) representatives and vendors.
Requires the ability to work independently to ensure protocol review implementation and ancillaries processes run smoothly.
High degree of analytic ability to manage the financial and human resources aspects of the position.
Interpersonal relationship skills needed to collaborate with others and work with functional group managers many hospital-wide department heads administrators and physicians in a positive and collegial fashion.
Comfortable using systems to create update maintain and disseminate data and reports.
Demonstrated project and program management skills; ability to prioritize initiatives and ensure timely execution and follow through
Proven ability to balance big picture strategic planning with specific and detail focused deliverables
Skilled and knowledgeable liaison between high level academics industry and philanthropic partners
Demonstrated time management and organization skills
Knowledge of current and developing pre-clinical and clinical research trends
Sound interpersonal skills
Works well independently and in groups; displaying initiative and diplomacy while maintaining important work relationships
Demonstrated ability to successfully manage multiple projects
Additional Job Details (if applicable)
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
Pay Range
- /Grade
7EEO 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
About Company
Patients at Mass General have access to a vast network of physicians, nearly all of whom are Harvard Medical School faculty and many of whom are leaders within their fields.