Brigham and Women's Hospital
SENIOR PROJECT MANAGER BWH TIMI STUDY GROUP
Brigham and Women's Hospital, Boston, Massachusetts, us, 02298
Description
In collaboration with the Sr. Director, Director, TIMI Principal Investigators, and Study Sponsors, establishes, maintains and complies with policies and procedures for assigned department/trial(s).Is knowledgeable of all aspects of assigned department/trial(s) to be able to evaluate questions and problems. Triages items to individuals with resources available to solve problems or answer questions.Directs internal staff involved in daily tasks performed in the TIMI Study Group to ensure smooth and efficient operations. Works with Sr. Director/Director in hiring, training, and evaluation of assigned support staff.In collaboration with Sr. Director/Director, works directly with external key stakeholders to ensure smooth operations for vendor and study sponsor management.In collaboration with Sr. Director/Director by writing memos, educational materials, newsletters, and articles. Creates presentations related to departmental/trial goals, strategies and outcomes.In collaboration with Sr. Director/Director in the design of reporting tools to capture necessary information to reach goals of the department/trials. Assists in re-design of reporting tools as a result of study design change or amendment.Designs and updates Manuals of Operation for assigned department/trial(s).Participates in internal and external audits. Works with Sr. Director/Director to design, implement, and evaluate departmental quality control activities.Identifies, organizes, and ensures accurate completion and retention of required departmental/ trial(s) regulatory documents and other relevant files.Keeps Sr. Director/Director informed of all issues, solutions and results by monitoring progress of departmental/trial(s) metrics on a regular basis. Must be able to interpret weekly report statistics, develop and implement action plans to address concerns when necessary.Participates in conference calls and departmental/trial(s) related meetings, presentations and trainings as requested. Prepares agenda and minutes. Ensures all supportive documentation is available to participants.Monitors expenditures and suggests modifications in expenditures as necessary or as directed by Sr. Director/Director.Demonstrate and maintains high level of knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to department/trials(s).Maintains department service standards, with particular attention to personal/behavioral, staff teamwork, and customer-staff interaction guidelines.Performs other tasks and responsibilities as directed.Qualifications
Bachelor's degree required6 to 7 years of Industry (domestic/international clinical trials) and/or other relevant experienceData management experienceSupervisory experienceClinical Trial CertificationTrial Budget experience preferredEEO Statement
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.Primary Location
MA-Boston-BWH Longwood Medical AreaWork Locations
BWH Longwood Medical Area75 Francis StreetBoston 02115Job
Professional/ManagerialOrganization
Brigham & Women's Hospital(BWH)Schedule
Full-timeStandard Hours
40Shift
Day JobEmployee Status
RegularRecruiting Department
BWH Department Of Medicine / Cardiovascular MedicineJob Posting
Aug 16, 2024
#J-18808-Ljbffr
In collaboration with the Sr. Director, Director, TIMI Principal Investigators, and Study Sponsors, establishes, maintains and complies with policies and procedures for assigned department/trial(s).Is knowledgeable of all aspects of assigned department/trial(s) to be able to evaluate questions and problems. Triages items to individuals with resources available to solve problems or answer questions.Directs internal staff involved in daily tasks performed in the TIMI Study Group to ensure smooth and efficient operations. Works with Sr. Director/Director in hiring, training, and evaluation of assigned support staff.In collaboration with Sr. Director/Director, works directly with external key stakeholders to ensure smooth operations for vendor and study sponsor management.In collaboration with Sr. Director/Director by writing memos, educational materials, newsletters, and articles. Creates presentations related to departmental/trial goals, strategies and outcomes.In collaboration with Sr. Director/Director in the design of reporting tools to capture necessary information to reach goals of the department/trials. Assists in re-design of reporting tools as a result of study design change or amendment.Designs and updates Manuals of Operation for assigned department/trial(s).Participates in internal and external audits. Works with Sr. Director/Director to design, implement, and evaluate departmental quality control activities.Identifies, organizes, and ensures accurate completion and retention of required departmental/ trial(s) regulatory documents and other relevant files.Keeps Sr. Director/Director informed of all issues, solutions and results by monitoring progress of departmental/trial(s) metrics on a regular basis. Must be able to interpret weekly report statistics, develop and implement action plans to address concerns when necessary.Participates in conference calls and departmental/trial(s) related meetings, presentations and trainings as requested. Prepares agenda and minutes. Ensures all supportive documentation is available to participants.Monitors expenditures and suggests modifications in expenditures as necessary or as directed by Sr. Director/Director.Demonstrate and maintains high level of knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to department/trials(s).Maintains department service standards, with particular attention to personal/behavioral, staff teamwork, and customer-staff interaction guidelines.Performs other tasks and responsibilities as directed.Qualifications
Bachelor's degree required6 to 7 years of Industry (domestic/international clinical trials) and/or other relevant experienceData management experienceSupervisory experienceClinical Trial CertificationTrial Budget experience preferredEEO Statement
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.Primary Location
MA-Boston-BWH Longwood Medical AreaWork Locations
BWH Longwood Medical Area75 Francis StreetBoston 02115Job
Professional/ManagerialOrganization
Brigham & Women's Hospital(BWH)Schedule
Full-timeStandard Hours
40Shift
Day JobEmployee Status
RegularRecruiting Department
BWH Department Of Medicine / Cardiovascular MedicineJob Posting
Aug 16, 2024
#J-18808-Ljbffr