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Job #03119

About our client Our client is the biotech division of a global, publicly traded pharmaceutical company with over 100,000 employees. They are at the forefront in the development and commercialization of therapeutics in multiple indications and are well known for high-quality standards and commitment to innovation. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Study Manager Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the coordination and execution of operational tasks related to the start-up, conduct and closeout of phase I – III clinical studies (local and multi-national) 2) Support the Clinical Project Manager to perform tasks related to start-up, conduct and closeout of phase I – III clinical studies 3) Facilitate communications among the Clinical Project Manager, Internal Team members and external providers 4) Organize and coordinate operational tasks with other internal and external partners (central laboratory, courier, etc.) 5) Edit, track and amend site contracts and budgets as well as vendor contracts and budgets (under the direction of the Clinical Project Manager) 6) Assist with developing, coordinating, tracking and reviewing study-specific documents (protocols and protocol amendments, CRFs and CRF completion guidelines, data validation guidelines, data management plans, etc.) 7) Review site regulatory documents for completeness and correctness 8) Follow-up with sites (as necessary) to obtain complete, correct and/or updated regulatory documents 9) Coordinate and facilitate study-specific operational tasks with the CRO as assigned (e.g. review of monitoring reports) 10) Plan and facilitate meetings/teleconferences with internal and external partners under the direction of the Clinical Project Manager 11) Prepare agendas, minutes and lists of action items in connection with meetings and assist team members to complete assigned action items in a timely manner 12) Extract data and compile study-specific information quickly and accurately for study-specific reports and summaries requested on an as needed basis by the Clinical Project Manager 13) Present clinical information at Investigator meetings and site initiation meetings (as requested by the Clinical Project Manager) 14) Co-monitor site qualification visits, initiation visits and recruitment motivational meetings at investigational sites and report quality issues to the Clinical Project Manager 15) Assist the Clinical Project Manager with the planning and conduct of Investigator meetings 16) Process Investigator payments or prepare budget projections if requested by the Clinical Project Manager 17) Prepare and maintain tracking tools to organize study information 18) Assist the Clinical Project Manager with reviewing of study deliverables, metrics and documentation as well as follow-up of study issues 19) Process drug shipments and participate in drug reconciliation, label reviewing, coordinating import licenses (as directed by the Clinical Project Manager) 20) Assist the Clinical Project Manager in project-specific training of the CRO and other internal and external Study Team personnel 21) Track shipment and other details of IND Safety Report letters (as requested by the Clinical Project Manager) 22) Assist Drug Safety in disseminating safety letters if requested by the Clinical Project Manager 23) Track site submission of IND Safety Report letters 24) Assist the Clinical Project Manager in responding to audit findings 25) Participate in process development and improvement activities at the direction of the Clinical Project Manager and Clinical Operations Director 26) Assist the Clinical Project Manager in preparing and sending specific project correspondence 27) Participate in SOP development and reviewing 28) Develop subject matter expertise in specialized areas, such as insurance, courier, working in South America, etc. 29) Participate in special working groups such as task forces on screen failures, drug manufacturing, or drug packaging, at the request of the Clinical Project Manager and Clinical Operations Director 30) Perform other duties and tasks as assigned Requirements 1) Bachelor’s degree in a relevant discipline or an appropriate mix of education and experience 2) 2 years of professional experience in clinical research, experience as a Clinical Research Associate or Study Coordinator 3) Experience in contracts and budgets 4) Experience in immunology or organ transplant studies 5) Experience in working with large documents 6) Background in GCP as demonstrated by specific coursework or job experience 7) Exposure to or experience in clinical site monitoring 8) Proficiency in medical terminology, drug names and drug classifications 9) Proficiency in Word and Excel (PowerPoint and Lotus Notes a plus) 10) Fluency in spoken and written English (other languages including German an asset) 11) Familiarity with EDC and other clinical applications a plus 12) Ability to multitask, plan and organize work 13) Self-motivated, self-starter with keen attention to detail 14) Willingness and ability to accept new tasks 15) Open-minded with ability to negotiate and follow through on commitments 16) Ability to prioritize and work in a team as well as independently 17) Highly responsible individual