Syneos Project Manager/临床项目经理

该职位来源于猎聘 FSP Global Company 负责二三期肿瘤项目 Job responsibilities Project AdministrationCreates and maintains the Trial Master File Management (TMF) Plan.Routinely reviews the TMF to ensure quality, completeness and inspection readinessCoordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors.Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closureAssists with identification of and contracting with approved vendors, as necessaryProvides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessaryAssists with development and implementation of change ordersAssists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently Financials/ReportingDevelops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones.Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior managementAssists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reportingAttends financial review meetings to assist with reconciliation and identification of budget overrunReviews and approves invoices from sites or vendors and to the client Knowledge/TrainingFacilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process trainingDevelops knowledge of current therapeutic environment Qualifications - External What we’re looking forBachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferredPrior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred.CRO and relevant therapeutic experience preferredStrong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirementsStrong organizational skillsStrong ability to manage time and work independentlyExcellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuadeFlexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environmentHigh level of competency in English languageProficiency with MS Office ApplicationsAbility to travel as necessary (up to 25%)