What are the responsibilities and job description for the Senior Clinical Research Project Manager position at Mass General Brigham?
Site: Mass General Brigham Incorporated
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
GENERAL SUMMARY/ OVERVIEW STATEMENT:
We seek an energetic, organized, and detail-oriented Senior Project Manager with experience in the conduct of clinical research studies. The Senior Project Manager will be responsible for providing managerial, logistical, and administrative direction for Dr. Michael Honigberg’s research group, including coordination of clinical trials and a collaborative network grant (American Heart Association Strategically Focused Research Network Center).
The Senior Project Manager in this role will work under the general direction of the Principal Investigator, physician investigators, and the Sr. Clinical Research Program Managers. The Senior Project Manager will be responsible for IRB and regulatory approval. The Senior Project Manager will plan and implement study protocols, create standard operating procedures, collect, and manage study data, assist in study activities, perform systematic literature reviews, and synthesize relevant data. The candidate will also prepare study progress reports and presentations and may provide support analysis and help with the preparation of manuscripts. Initial focus will be launching the study, IRB application, and ensuring each staff member is fully trained. The Project Manager will recruit and enroll participants to the study. They will be responsible for data entry and management. In addition, the Project Manager will manage invoicing for all active research studies; assist with coordination and development of budgets and contracts; develop appropriate databases for tracking scientific, financial, and administrative information; develop best practices; create standard operating procedures (SOP’s); train new research staff members; as well as assist professional staff in the dissemination of research and operational efforts through presentations and written material. The position requires strong leadership and project development skills. While this is not a clinical position, it requires a good knowledge of basic clinical concepts and an understanding of how and when to communicate with clinicians. The Project Manager position requires the ability to be highly self-directing, resourceful, professional, and organized. The Project Manager will help ensure smooth communication and follow-up among all staff working with study subjects.
The candidate must demonstrate superior organizational, time management, and communication skills, as well as intellectual independence and initiative. He/she will protect confidential and sensitive research data with integrity. The ability to work both independently and as part of a team is essential to this job. Other job duties and responsibilities are listed in detail below. This is a full-time (40 hours/week) position; evening and occasional weekend hours will be required.
Qualifications
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The Senior Project Manager Will Act As a Critical Liaison Between MGH And The Other Participating Sites In The Strategically Focused Research Network Center. The Senior Project Manager Will
Present reports defining project progress, problems, and solutions Implement new initiatives to support research mission and goals of excellence Liaise with Research Management, Partners Human Research Committee, Research Ventures and Licensing, Partners Clinical Trials Office, and other MGH and Department groups on Project initiatives or performance improvements Organize, facilitate, and implement operational meetings, training seminars, and study-specific team meetings Manage invoicing and reconciliation of payments for all clinical research studies Develop, monitor, and report on study budgets Provide fundraising and grant-writing assistance as necessary Serve as a project administrator, working on systems improvement, project development and establishment of project SOPs Coordinate and supervise efforts for studies and provide guidance to the study specific staff in protocol implementation, meeting recruitment goals, performing clinical procedures, and managing data collection Establish recruitment strategies and assure implementation and goal attainment on trials and other funded research Monitor study performance for subject accession and data acquisition in accordance with the protocols and conveys information to PI Work with marketing staff to create print and web presence/material about the studies Assess educational needs of investigators and study staff; design training projects and conduct or facilitate individual and/or group training sessions Lead performance improvement initiatives for the study staff to ensure that researchers are in the best environment to succeed Serve as primary resource for all regulatory and operational aspects of the studies, overseeing submission and maintenance of documentation Design and implement quality assurance systems to assure compliance Assist with expediting funding and study start-up at MGH and other participating centers Oversee collection and integrity of study data Oversee regulatory affairs of the study Field study staff questions on a day-to-day basis Meet regularly with study PI, research coordinators, and other members of the research team Assist with audit preparation as necessary Accept responsibilities for special projects as requested
Qualifications
A minimum of 5 to 7 years of clinical research experience interacting with patients and the medical system as related to the duties and responsibilities specified. Experience with IRB administration and data management is required.
Bachelor’s degree required; master’s degree preferred.
Skills/ Abilities/ Competencies Required
Duties will be performed in clinical and office settings.
Supervisory Responsibility
Will participate in the training, orientation and education of research staff/coordinators, interns, and volunteers.
Fiscal Responsibility
With the help of a Grant Manager, the incumbent will be responsible for developing, monitoring, and providing regular updates to the PI on study budgets. The Project Manager will be responsible for the purchasing of study-related equipment and supplies as needed.
Additional Job Details (if Applicable)
Remote Type
Remote
Work Location
185 Cambridge Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
EEO Statement
Mass General Brigham Incorporated 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.
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.
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
GENERAL SUMMARY/ OVERVIEW STATEMENT:
We seek an energetic, organized, and detail-oriented Senior Project Manager with experience in the conduct of clinical research studies. The Senior Project Manager will be responsible for providing managerial, logistical, and administrative direction for Dr. Michael Honigberg’s research group, including coordination of clinical trials and a collaborative network grant (American Heart Association Strategically Focused Research Network Center).
The Senior Project Manager in this role will work under the general direction of the Principal Investigator, physician investigators, and the Sr. Clinical Research Program Managers. The Senior Project Manager will be responsible for IRB and regulatory approval. The Senior Project Manager will plan and implement study protocols, create standard operating procedures, collect, and manage study data, assist in study activities, perform systematic literature reviews, and synthesize relevant data. The candidate will also prepare study progress reports and presentations and may provide support analysis and help with the preparation of manuscripts. Initial focus will be launching the study, IRB application, and ensuring each staff member is fully trained. The Project Manager will recruit and enroll participants to the study. They will be responsible for data entry and management. In addition, the Project Manager will manage invoicing for all active research studies; assist with coordination and development of budgets and contracts; develop appropriate databases for tracking scientific, financial, and administrative information; develop best practices; create standard operating procedures (SOP’s); train new research staff members; as well as assist professional staff in the dissemination of research and operational efforts through presentations and written material. The position requires strong leadership and project development skills. While this is not a clinical position, it requires a good knowledge of basic clinical concepts and an understanding of how and when to communicate with clinicians. The Project Manager position requires the ability to be highly self-directing, resourceful, professional, and organized. The Project Manager will help ensure smooth communication and follow-up among all staff working with study subjects.
The candidate must demonstrate superior organizational, time management, and communication skills, as well as intellectual independence and initiative. He/she will protect confidential and sensitive research data with integrity. The ability to work both independently and as part of a team is essential to this job. Other job duties and responsibilities are listed in detail below. This is a full-time (40 hours/week) position; evening and occasional weekend hours will be required.
Qualifications
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The Senior Project Manager Will Act As a Critical Liaison Between MGH And The Other Participating Sites In The Strategically Focused Research Network Center. The Senior Project Manager Will
Present reports defining project progress, problems, and solutions Implement new initiatives to support research mission and goals of excellence Liaise with Research Management, Partners Human Research Committee, Research Ventures and Licensing, Partners Clinical Trials Office, and other MGH and Department groups on Project initiatives or performance improvements Organize, facilitate, and implement operational meetings, training seminars, and study-specific team meetings Manage invoicing and reconciliation of payments for all clinical research studies Develop, monitor, and report on study budgets Provide fundraising and grant-writing assistance as necessary Serve as a project administrator, working on systems improvement, project development and establishment of project SOPs Coordinate and supervise efforts for studies and provide guidance to the study specific staff in protocol implementation, meeting recruitment goals, performing clinical procedures, and managing data collection Establish recruitment strategies and assure implementation and goal attainment on trials and other funded research Monitor study performance for subject accession and data acquisition in accordance with the protocols and conveys information to PI Work with marketing staff to create print and web presence/material about the studies Assess educational needs of investigators and study staff; design training projects and conduct or facilitate individual and/or group training sessions Lead performance improvement initiatives for the study staff to ensure that researchers are in the best environment to succeed Serve as primary resource for all regulatory and operational aspects of the studies, overseeing submission and maintenance of documentation Design and implement quality assurance systems to assure compliance Assist with expediting funding and study start-up at MGH and other participating centers Oversee collection and integrity of study data Oversee regulatory affairs of the study Field study staff questions on a day-to-day basis Meet regularly with study PI, research coordinators, and other members of the research team Assist with audit preparation as necessary Accept responsibilities for special projects as requested
Qualifications
A minimum of 5 to 7 years of clinical research experience interacting with patients and the medical system as related to the duties and responsibilities specified. Experience with IRB administration and data management is required.
Bachelor’s degree required; master’s degree preferred.
Skills/ Abilities/ Competencies Required
- Excellent interpersonal and management skills with facility to interact professionally at all levels and plan and initiate new activities.
- Ability to design, prepare, deliver, and evaluate SOPs, source documents and other documents.
- Ability to compile and manage data, analyze information, and produce reports.
- Clinical knowledge as required for patient interviews and chart reviews.
- Knowledge and experience with human subjects research and IRB requirements.
- Administrative skills to meet the regulatory compliance required by IRB reporting.
- Excellent written and verbal communication skills.
- High level time management skills requiring exceptional organizational skills and the ability to organize time and prioritize effectively. This includes the ability to ask for direction when appropriate and the flexibility to handle multiple tasks and deadline pressures.
- Experience with common PC computer software including Microsoft Word, PowerPoint, Excel, Outlook, and reference management software such as Reference Manager or EndNote.
- Facility with learning new computer applications.
- Perform literature searches using PubMed and other search engines and perform Internet searches using MS Internet Explorer and various search engines.
- Good proofreading skills.
- Ability to compile and manage data, analyze information, and produce reports.
- Assist with materials management, supply, inventory, and ordering of program materials.
- Excellent critical thinking skills and ability to work independently are essential
- Must be self-motivated, and highly resourceful
- Excellent verbal and written communication skills
- Excellent discretion and judgment with the ability to problem solve independently, and knowing when to escalate to leadership
- Flexibility and organizational skills in a fast-paced, complex environment
- Ability to navigate within a complex organization, e.g. to understand fit with organizational goals/priorities, build consensus, facilitate decision-making
- Ability to maintain the utmost confidentiality of sensitive and personal information
- Strong computer skills--Proficiency in Word, PowerPoint, Excel--are essential
- Ability to develop templates, organize technical information, and maintain functional schedules
- Ability to educate and conduct training sessions both on individual and group levels
- Knowledge of and compliance with all hospital, State, and Federal regulatory requirements, including hospital policy and procedures, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Comfort interacting and communicating effectively with high-level hospital administration, physicians, Principal Investigators, all levels of hospital staff, external funding agencies, and maintain a variety of internal and external contacts
Duties will be performed in clinical and office settings.
Supervisory Responsibility
Will participate in the training, orientation and education of research staff/coordinators, interns, and volunteers.
Fiscal Responsibility
With the help of a Grant Manager, the incumbent will be responsible for developing, monitoring, and providing regular updates to the PI on study budgets. The Project Manager will be responsible for the purchasing of study-related equipment and supplies as needed.
Additional Job Details (if Applicable)
Remote Type
Remote
Work Location
185 Cambridge Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
EEO Statement
Mass General Brigham Incorporated 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.
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.
