Brigham and Women’s Hospital
Research Project Manager, Radiology
Brigham and Women’s Hospital, Boston, Massachusetts, us, 02298
Job Description - Research Project Manager, Radiology (3306515)
The BWH Amyloidosis program is an internationally-recognized multidisciplinary program dealing with the uncommon disease, amyloidosis. The Research Project Manager (RPM) will have the opportunity to oversee cutting-edge industry and investigator-initiated clinical trials while interfacing with pharmaceutical/biotech experts, research organizations, and physician investigators in a multidisciplinary fashion.
The RPM will also be responsible for the team’s execution on a daily basis, of the procedural, managerial, and policy decisions made for the studies. Executes and coordinates daily clinical research activities across a number of protocols including laboratory data collection protocols. Participates in all decisions made for the study and identifies modifications of existing policies and procedures. Works across departments and specialties in multidisciplinary trials.
Responsible for budget oversight, training other team members, developing and keeping SOPs current for the unit and participating in supporting grant writing and proposals overseen by the director. Oversees the day-to-day activities of clinical trial coordinator(s), research assistant(s), and CCI/temporary support staff as needed, depending on workflow fluctuations.
Trials Operations
The project manager is responsible for all operational aspects of clinical trial oversight including the timely delivery of each study within budget boundaries. Responsible for the coordination and implementation of research design processes and study protocols for multiple clinical trials. Ensures that required regulatory documents are completed by the team. Works with the PI and the trial sponsor/contracted research organization to complete trial agreements. Communicates effectively and promptly with sponsor contacts and with the PI regarding agreement language. Oversees applications to the IRB, including new application, amendment, continuing reviews, SAE’s, etc. for all new and existing study proposals. Working in concert with the Director, Principal Investigator and/or Clinical Trials Coordinators, develops and implements patient recruitment strategies and ensures recruitment goals are met. Defines and monitors key performance indicators and departmental metrics for Clinical Operations and identifies opportunities to optimize processes, procedures (SOPs, Work Instructions) and cost. Provide efficient updates on trial progress to the Director of Clinical Trials, Department Administrator, and/or Administrator. Attends regular scheduled internal clinical trials meetings as well as any other management meetings at the discretion of Amyloidosis Program senior physician staff and/or Department Administrator. Develops, organizes, and/or maintains the study database for individual studies. Responsible for data validation and quality control. Serves as the primary contact for outside vendors utilized to ensure efficient operation of the study. Directly responds to inquiries regarding study protocol and policy. Must be accessible to study participants in order to screen adverse events, concerns and questions related to the investigational drug protocol. Participates in all decisions made for the study and the formulation of policies and procedures. Identifies modifications needed and works to implement solutions. Monitors and reports on the financial performance of each study. Reconciles the financials of every trial each month. In coordination with Department Administrator and Grant Administrator, manages the development and oversight of Unit’s budget. Human Resources
Directly manages Clinical Unit for Research and Innovation in Trials staff with responsibility for staff training, performance management, setting individual employee goals and career growth opportunities for staff. Supervises 2-4 research assistants; ensuring they meet their job responsibilities. Maintains appropriate GCP/CITI, study-specific and other required trainings for all faculty and staff participating in clinical trials activities. Participates in grant writing, proposal writing and/or manuscript development. All other duties as assigned. Minimum Qualifications
BS Required, MS preferred. Educational and practical experience in laboratory sciences is an advantage. Minimum of 5 years of progressively more responsible research work experience. Prior supervisory experience required. Minimum of 3 years of prior experience in clinical trials or relevant employment in industry such as a CRO monitor. More than 3 years of experience with exposure to IRB preparation, interactions with CROs, site monitors, regulatory paperwork, consenting, and interacting with study subjects. Excellent interpersonal skills are required for working with study participants and multiple parties involved in the trials process. Supervisory experience is required. Excellent organizational skills and ability to prioritize a variety of tasks. Excellent oral and written communication skills. High degree of computer literacy. BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.
#J-18808-Ljbffr
The project manager is responsible for all operational aspects of clinical trial oversight including the timely delivery of each study within budget boundaries. Responsible for the coordination and implementation of research design processes and study protocols for multiple clinical trials. Ensures that required regulatory documents are completed by the team. Works with the PI and the trial sponsor/contracted research organization to complete trial agreements. Communicates effectively and promptly with sponsor contacts and with the PI regarding agreement language. Oversees applications to the IRB, including new application, amendment, continuing reviews, SAE’s, etc. for all new and existing study proposals. Working in concert with the Director, Principal Investigator and/or Clinical Trials Coordinators, develops and implements patient recruitment strategies and ensures recruitment goals are met. Defines and monitors key performance indicators and departmental metrics for Clinical Operations and identifies opportunities to optimize processes, procedures (SOPs, Work Instructions) and cost. Provide efficient updates on trial progress to the Director of Clinical Trials, Department Administrator, and/or Administrator. Attends regular scheduled internal clinical trials meetings as well as any other management meetings at the discretion of Amyloidosis Program senior physician staff and/or Department Administrator. Develops, organizes, and/or maintains the study database for individual studies. Responsible for data validation and quality control. Serves as the primary contact for outside vendors utilized to ensure efficient operation of the study. Directly responds to inquiries regarding study protocol and policy. Must be accessible to study participants in order to screen adverse events, concerns and questions related to the investigational drug protocol. Participates in all decisions made for the study and the formulation of policies and procedures. Identifies modifications needed and works to implement solutions. Monitors and reports on the financial performance of each study. Reconciles the financials of every trial each month. In coordination with Department Administrator and Grant Administrator, manages the development and oversight of Unit’s budget. Human Resources
Directly manages Clinical Unit for Research and Innovation in Trials staff with responsibility for staff training, performance management, setting individual employee goals and career growth opportunities for staff. Supervises 2-4 research assistants; ensuring they meet their job responsibilities. Maintains appropriate GCP/CITI, study-specific and other required trainings for all faculty and staff participating in clinical trials activities. Participates in grant writing, proposal writing and/or manuscript development. All other duties as assigned. Minimum Qualifications
BS Required, MS preferred. Educational and practical experience in laboratory sciences is an advantage. Minimum of 5 years of progressively more responsible research work experience. Prior supervisory experience required. Minimum of 3 years of prior experience in clinical trials or relevant employment in industry such as a CRO monitor. More than 3 years of experience with exposure to IRB preparation, interactions with CROs, site monitors, regulatory paperwork, consenting, and interacting with study subjects. Excellent interpersonal skills are required for working with study participants and multiple parties involved in the trials process. Supervisory experience is required. Excellent organizational skills and ability to prioritize a variety of tasks. Excellent oral and written communication skills. High degree of computer literacy. BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.
#J-18808-Ljbffr