CLINICAL RESEARCH MANAGER -- CANCER CENTER PROTOCOL OFFICE

DescriptionGENERAL OVERVIEWThe Program for the Coordination and Oversight of Research Protocols (PCORP) within the MGH Cancer Center Protocol Office specializes in the central coordination, monitoring and regulatory oversight of Investigator-initiated, multi-center clinical trials. PCORP is seeking candidates experienced in clinical trial coordination and implementation to provide managerial, operational and supervisory oversight for a team of research coordinators/monitors and their respective research trials. The Clinical Research Project Manager will independently direct a team of research staff to coordinate, monitor and advance a portfolio of therapeutic oncology trials from concept through completion. Project Manager responsibilities include direct management of individual projects in addition to the hiring, training and first-line supervision of a team of research staff on the activities of a broader research portfolio. The Project Manager has oversight responsibility of the team’s timeline management, clinical quality assessment and trial operations integrity and for ensuring Sponsor-Investigator and Site Investigator compliance with Federal and local regulatory requirements.PRINCIPAL RESPONSIBILITIESTrial and portfolio coordination:Coordination, regulatory maintenance, monitoring and timeline management of several multi-center clinical trials within the Cancer CenterOngoing evaluation and verification of protocol procedures, regulatory and data compliance and alignment with federal and local regulations across all participating sites Acting as central communications liaison for all clinical trial collaboratorsWorking directly with entities within and outside the organization, including Investigators, funding sponsors, collaborators and vendors to establish workflow, monitor process and identify and resolve issues Identifying variance across participating sites’ Standard Operating Procedures and developing processes to ensure complianceRoutine and expedited reporting to all funding sponsors, monitoring boards, regulatory boards or other governing agencies (e.g. FDA, IRB, DSMB, etc) Assisting and consulting with Senior PCORP Management on global program initiatives, including networking, program expansion and process improvementStaying current with federal and local regulations, guidance and quality assurance trends as they pertain to the conduct of clinical research.Occasional domestic travel requiredSupervisory:Hiring and training of new staff and assessment of ongoing continuing education and development needs of superviseesFirst-line supervision and direction of 4-6 remote FTEs, with direct consultation on individual research portfolio coordination and prioritization of project assignmentsExecuting performance evaluation, staff development and corrective action processes for direct report research staff, as neededQualificationsQualifications:BA/BS degree required, Master’s preferred3-5 years related clinical research experience and minimum 1 year management experience requiredPrior supervisory experience preferredSkills Required:Exceptional time management skills with the capacity to prioritize among multiple tasks and change direction in response to fluctuating demandsExcellent written and verbal communication skillsAbility to clarify and distill complex issues to a variety of collaboratorsAble to work successfully in a remote environment while demonstrating and fostering initiative and accountabilityAble to manage diverse teams with different skillsets, work styles, and professional rolesMotivated to help team achieve results and meet deadlinesIdentifies key priorities and helps manage change and ambiguityKeen ability to anticipate and address potential issues proactivelyProblem-solving skills, including the ability to gather information, identify resources, and develop alternativesFamiliarity with the Code of Federal Regulation (CFR) and Good Clinical Practice (ICH GCP)Knowledge of current and developing clinical research trendsSupervisory ResponsibilityOrients, trains and supervises up to 5 FTEs staff membersWorking EnvironmentDuties will mainly be performed in a remote setting; limited in-office presence anticipated. Applicants may work in all states with the following exceptions: OH, WY, WA, ND, Puerto Rico, and the U.S. Virgin IslandsOccasional domestic travel requiredPosition focuses on central trial coordination and does not include patient contactJob Field: Research - OtherOrganization: Massachusetts General Hospital(MGH)Schedule: Full-timeShift: Day JobEmployee Status: Regular