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Job #02733

About our client Our client is 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 (In-House CRA) Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Support Clinical Project Manager to perform tasks related to start-up, conduct and closeout of phase I – III clinical studies 2) Facilitate communication among the Clinical Project Manager, internal team members and external providers 3) Organize and coordinate operational tasks with other internal and external partners (central laboratory, courier, etc.) under the direction of the Clinical Project Manager 4) Edit, track, and amend site and vendor contracts as well as their budgets 5) Assist with the development, coordination, tracking and review of study-specific documents, including protocols and protocol amendments, CRFs and CRF completion guidelines, data validation guidelines, data management plans, statistical analysis plans, ICFs, monitoring plans, and clinical study reports 6) Review site regulatory documents for completeness and correctness 7) Follow-up with sites (as necessary) to obtain complete, correct and/or updated regulatory documents 8) Coordinate and facilitate study-specific operational tasks (e.g. review of monitoring reports) with the CRO as assigned 9) Plan and facilitate meetings/teleconferences with internal and external partners under the direction of the Clinical Project Manager and prepare agendas, minutes and lists of action items for these meetings 10) Assist team members to complete assigned action items in a timely manner 11) Extract data and compile study-specific information quickly and accurately for study-specific reports and summaries (as requested by the Clinical Project Manager) 12) Present clinical information at investigator meetings and site initiation meetings (as requested by the Clinical Project Manager) 13) Co-monitor site qualification visits, initiation visits and recruitment motivational meetings at investigational sites as well as report quality issues to the Clinical Project Manager 14) Assist the Clinical Project Manager with the planning and conduct of investigator meetings 15) Process investigator payments or prepare budget projections as requested by the Clinical Project Manager 16) Assist the Clinical Project Manager with the review of study deliverables and metrics, documentation, and follow-up of study issues 17) Prepare and maintain tracking tools to organize study information 18) Assist the Clinical Project Manager in project-specific training of the CRO and other internal and external study team personnel 19) Process drug shipments and participate in drug reconciliation, label reviewing and coordinating import licenses (as directed by the Clinical Project Manager) 20) Assist Drug Safety in disseminating safety letters (if requested by the Clinical Project Manager) 21) Track shipment and other details of IND Safety Report letters (if requested by the Clinical Project Manager) 22) Assist the Clinical Project Manager in preparing and sending specific project correspondence 23) Track site submission of IND Safety Report 24) Assist the Clinical Project Manager in responding to audit findings 25) Perform other duties and tasks as assigned Requirements 1) Bachelor’s degree or higher in a relevant discipline/RN 2) 2 years of professional experience in clinical research, including experience as an in-house/Junior CRA or minimum 5 years of experience as a Coordinator 3) 2+ years of experience in clinical trials 4) Excellent experience in and understanding of GCPs 5) Experience in clinical site monitoring 6) In-depth understanding of EDC and other clinical applications a plus 7) Experience in oncology, immunology or organ transplant studies a plus 8) Excellent knowledge of medical terminology, drug names and drug classifications 9) Experience in working with large documents preferred 10) Experience in contracts and budgets preferred 11) Proficiency in Word and Excel (PowerPoint and Lotus Notes a plus) 12) Ability to multitask 13) Self-motivated and self-starter 14) Keen attention to detail