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Senior Clinical Research Program/Project Manager

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Company :
Massachusetts General Hospital

Location :
Boston, Massachusetts

Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT

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Description :
Senior Clinical Research Program/Project Manager Functions independently as Senior Project Manager and is responsible for the planning and implementation of all phases of several currently funded clinical trials, as well as the initial stages for future trials. The team is focused on cardiovascular disease and improving cardiovascular outcomes. Currently funded multicenter trials include NIH studies (STOP-CA, REPRIEVE-MR) and a new, untitled, 4-year industry study testing whether an immune therapy can reduce the risk of cardiac events in patients on a cancer therapy. Indeed, a major focus of the program is reducing cardiovascular events among patients with cancer. Working directly with the Principal Investigator, multiple Co-Investigators, CROs and funding agencies, the Senior Project Manager is responsible for start-up planning; finalization of protocol and forms including IRBs; arrangement for study drug packaging and blood kits; development of staffing plan/hiring/space needs; and writing and revising the study Manual of Operations and numerous other study documents; monitoring all procedures for these complex and highly public studies; and representing the Center for Cardiovascular Disease Prevention at MGH at numerous meetings nationwide and on several weekly teleconference calls and webinars. The Project Manager is also responsible for analogous activities for recently completed trials which may be in the active data analysis period (for the next several years). PRINCIPAL DUTIES AND RESPONSIBILITIES: Responsible for all aspects of project direction and study coordination for numerous NIH and industry funded studies. Contributes to the content and development of numerous data forms and documents for multiple trials and research studies. Directs supplier of study drug/placebo, prepares IND application to FDA if needed, develops timeline for manufacture and distribution of drug supply to subjects. Designs and writes recruitment materials, publicity and newsletters to meet patient enrollment goals in compliance with IRB regulations. Develops and implements operational procedures for studies to logically and effectively sequence and structure the protocol-required study procedures as part of responsibility for all aspects of study direction and administration. Supervises the preparation of all documentation for securing IRB approval, and then ensuring on-going IRB approval for the study and study sites. Liaison to sponsors (industry and NIH), internal and external laboratories, on-site research collaborators, and relevant hospital departments to coordinate specific trial activities. Ensures ongoing data integrity by being responsible for quality control of data. Develops and amends standard manual of operating procedures and study protocol documents. Responsible for preparation of reports and resource for the PI, Co-Investigators, Partners HealthCare, NIH, industry sponsors, CRO, local and central IRBs, and FDA. Assisting sites with IRB approval and documentation as well as compliance with good clinical practice and clinical study. Assisting with data transfer from sites, data storage and QC and QA of study data. Consults with sponsors, including NIH, and other divisional research entities to design methods to ensure compliance with protocol procedures and regulatory requirements to protect subject safety and privacy. Oversees hiring, evaluation, discipline, firing, training and orientation of a staff; has overall responsibility for supervision of staff. Represents the Center at numerous national (and occasional international) meetings, and weekly webinars. Perform other duties, as requested or required. For all positions that include direct patient care, indicate with an ‘X’ the age(s) of all patient populations served No Direct Patient Care QUALIFICATIONS: BA/BS degree required. Masters degree preferred. Minimum of 7 years progressively more responsible experience in clinical research. Knowledge of federal regulatory requirements for good clinical practice of trials. Prior experience with all aspects of NIH-sponsored clinical trials. Prior experience with design and management of clinical trials required. Excellent communication skills. SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: Must be able to make independent, effective and appropriate decisions in numerous situations Excellent judgment and ability to understand, interpret and implement protocol requirements Excellent organizational skills to formulate long term complex procedure requirements in compliance with vigorous and competing timetables Knowledge of federal and local regulatory guidelines with respect to the conduct and fulfillment of clinical trial documentation Strong interpersonal, leadership and team-building skills and the ability to smoothly integrate the demands of sponsor, hospital and other groups necessary to perform all aspects of multiple clinical trials being run concurrently Excellent written and communication skills Ability to work with a diverse set of constituencies from countries world-wide. Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged. MA-Boston-MGH Main Campus MGH Main Campus (MGHMAIN) 55 Fruit Street Boston, 02114 MGH Main Campus 55 Fruit Street Boston Research-Management Massachusetts General Hospital(MGH) Full-time Day Job Regular MGH Radiology Research May 14, 2021