Brigham and Women’s Hospital
Project Manager Timi BWH Cardiovascular
Brigham and Women’s Hospital, Boston, Massachusetts, us, 02298
Job Description - Project Manager Timi BWH Cardiovascular (3314885)
General Summary
Working directly with the Sr. Director/Director, this position has complete responsibility for the day-to-day operational project management of assigned department/trial(s) within the TIMI Study Group. The TIMI Study Group is an Academic Research Organization whose principal goal is to conduct high-quality multi-center, national and international clinical trials that enhance the care of patients with coronary artery disease.
Responsibilities
In collaboration with the Sr. Director, Director, TIMI Principal Investigators, and Study Sponsors, establish, maintain and comply with policies and procedures for assigned department/trial(s). Manage 1-2 global CV outcomes trials that typically involve ~10,000 patients enrolled at >500 sites in >30 countries, with follow-up for 5 years. Manage International Steering Committee, Data Monitoring Committee, and Clinical Events Committee. Be knowledgeable of all aspects of assigned department/trial(s) to evaluate questions and problems. Triage items to individuals with resources available to solve problems or answer questions. Direct internal staff involved in daily tasks performed in the TIMI Study Group to ensure smooth and efficient operations. Work with Sr. Director/Director in hiring, training, and evaluation of assigned support staff. Actively assist Sr. Director/Director by writing memos, educational materials, newsletters, and articles. Create presentations related to departmental/trial goals, strategies, and outcomes. Assist Sr. Director/Director in the design of reporting tools to capture necessary information to reach goals of the department/trials. Assist in re-design of reporting tools as a result of study design change or amendment. Design and update Manuals of Operation for assigned department/trial(s). Participate in internal and external audits. Identify, organize, and ensure accurate completion and retention of required departmental/trial(s) regulatory documents and other relevant files. Keep Sr. Director/Director informed of all issues, solutions, and results by monitoring progress of departmental/trial(s) metrics on a regular basis. Interpret weekly report statistics and develop and implement action plans to address concerns when necessary. Liaise with external vendors and/or related parties as a department/trial(s) representative to ensure smooth management of department/trial(s). Participate in conference calls and departmental/trial(s) related meetings, presentations, and trainings as requested. Prepare agenda and minutes. Ensure all supportive documentation is available to participants. Prepare presentations for the three annual scientific cardiology sessions and investigator meetings. Monitor expenditures and suggest modifications in expenditures as necessary or as directed by Sr. Director/Director. Demonstrate and maintain a high level of knowledge of regulations, clinical research conduct, laws, guidelines, and standards relating to department/trials(s). Maintain department service standards, with particular attention to personal/behavioral, staff teamwork, and customer-staff interaction guidelines. Perform other tasks and responsibilities as directed. Minimum Requirements
Minimum of Bachelor’s degree and experience in a health/research-related field. Minimum of 5 years of progressively more responsible research work experience. Experience with computers and data management systems. Supervisory Experience required. Clinical Trial Certification Preferred. Skills
Ability to accept a high degree of authority and responsibility for major decision-making as it relates to the conduct of large domestic and international clinical trials. Excellent judgment and ability to interpret information and protocol requirements, and initiate appropriate actions given competing priorities. Outstanding interpersonal and leadership skills to effectively interact with research coordinators, principal investigators, and to represent TIMI Study Group to sponsors and regulatory authorities (domestic and international). Outstanding written and oral communication skills to work with individuals from various fields of expertise and with participants from various backgrounds, and to function effectively as a member of a research team. Outstanding organizational abilities to formulate and complete rigorous timetables. Strong presentation skills. Busy office environment with frequent deadlines. In conjunction with Sr. Director and Director, supervise support staff of 2 to 10 individuals. In conjunction with Sr. Director and Director, responsible for oversight of the assigned trial or department budget. Location MA-Boston-BWH Longwood Medical Area Work Locations BWH Longwood Medical Area, 75 Francis Street Job Type Professional/Managerial Organization Brigham & Women's Hospital (BWH) Schedule Full-time, Standard Hours 40 Shift Day Job Employee Status Regular 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. 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.
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In collaboration with the Sr. Director, Director, TIMI Principal Investigators, and Study Sponsors, establish, maintain and comply with policies and procedures for assigned department/trial(s). Manage 1-2 global CV outcomes trials that typically involve ~10,000 patients enrolled at >500 sites in >30 countries, with follow-up for 5 years. Manage International Steering Committee, Data Monitoring Committee, and Clinical Events Committee. Be knowledgeable of all aspects of assigned department/trial(s) to evaluate questions and problems. Triage items to individuals with resources available to solve problems or answer questions. Direct internal staff involved in daily tasks performed in the TIMI Study Group to ensure smooth and efficient operations. Work with Sr. Director/Director in hiring, training, and evaluation of assigned support staff. Actively assist Sr. Director/Director by writing memos, educational materials, newsletters, and articles. Create presentations related to departmental/trial goals, strategies, and outcomes. Assist Sr. Director/Director in the design of reporting tools to capture necessary information to reach goals of the department/trials. Assist in re-design of reporting tools as a result of study design change or amendment. Design and update Manuals of Operation for assigned department/trial(s). Participate in internal and external audits. Identify, organize, and ensure accurate completion and retention of required departmental/trial(s) regulatory documents and other relevant files. Keep Sr. Director/Director informed of all issues, solutions, and results by monitoring progress of departmental/trial(s) metrics on a regular basis. Interpret weekly report statistics and develop and implement action plans to address concerns when necessary. Liaise with external vendors and/or related parties as a department/trial(s) representative to ensure smooth management of department/trial(s). Participate in conference calls and departmental/trial(s) related meetings, presentations, and trainings as requested. Prepare agenda and minutes. Ensure all supportive documentation is available to participants. Prepare presentations for the three annual scientific cardiology sessions and investigator meetings. Monitor expenditures and suggest modifications in expenditures as necessary or as directed by Sr. Director/Director. Demonstrate and maintain a high level of knowledge of regulations, clinical research conduct, laws, guidelines, and standards relating to department/trials(s). Maintain department service standards, with particular attention to personal/behavioral, staff teamwork, and customer-staff interaction guidelines. Perform other tasks and responsibilities as directed. Minimum Requirements
Minimum of Bachelor’s degree and experience in a health/research-related field. Minimum of 5 years of progressively more responsible research work experience. Experience with computers and data management systems. Supervisory Experience required. Clinical Trial Certification Preferred. Skills
Ability to accept a high degree of authority and responsibility for major decision-making as it relates to the conduct of large domestic and international clinical trials. Excellent judgment and ability to interpret information and protocol requirements, and initiate appropriate actions given competing priorities. Outstanding interpersonal and leadership skills to effectively interact with research coordinators, principal investigators, and to represent TIMI Study Group to sponsors and regulatory authorities (domestic and international). Outstanding written and oral communication skills to work with individuals from various fields of expertise and with participants from various backgrounds, and to function effectively as a member of a research team. Outstanding organizational abilities to formulate and complete rigorous timetables. Strong presentation skills. Busy office environment with frequent deadlines. In conjunction with Sr. Director and Director, supervise support staff of 2 to 10 individuals. In conjunction with Sr. Director and Director, responsible for oversight of the assigned trial or department budget. Location MA-Boston-BWH Longwood Medical Area Work Locations BWH Longwood Medical Area, 75 Francis Street Job Type Professional/Managerial Organization Brigham & Women's Hospital (BWH) Schedule Full-time, Standard Hours 40 Shift Day Job Employee Status Regular 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. 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.
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