Senior Project Manager
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![]() United States, Massachusetts, Boston | |
![]() 125 Nashua Street (Show on map) | |
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Summary
Responsible for all aspects of project administration and coordination of multiple clinical trials including multi-center trials. Duties include the review of all proposals, budgets, and contracts and tracking of all milestones and timelines. The development of study related documents, completion of data management functions, and reporting of safety and endpoints to the study sponsor and IRB. For multi-site trials, the overall direction of the clinical sites for protocol adherence is under the direction. Accountable for assuring that the project team that he/she leads meets all deadlines and is also required to maintain a close effectual working relationship with Sponsors, Study Coordinators, and Principal Investigators. Does this position require Patient Care? No Essential Functions -Coordinate the development of investigator-initiated and industry sponsored project documents and timelines and manage any changes, including future timeline changes that may result from changes in scope, delays in schedule or resource constraints. -Is responsible for all regulatory maintenance for assigned clinical research and trial projects including IRB submissions, biosafety committee submissions, FDA submissions and reporting, funding agency reporting, clinicaltrials.gov record maintenance, and other related tasks on assigned projects. -Monitors and manages sub-sites on multi-center clinical research projects including facilitating regular sub-site status meetings, overseeing sub-site data collection and quality, and collecting sub-site regulatory documentation and ensuring compliance. -Develop and finalize complete project plans with formalized project milestones and deliverables. -Facilitate and maintain records of all internal and external communication relevant to assigned clinical trials. -Responsible for Project Operating Planning Manual development. -Present and lead presentations at site initiations or trial kick off meetings. Education Physical Requirements
The General Hospital Corporation is an Equal Opportunity 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. |