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Syneos FSP 外資 Global Pharma 主要負(fù)責(zé)生殖腫瘤 泌尿腫瘤項目 Job responsibilities Project Administration ? Creates and maintains the Trial Master File Management (TMF) Plan. Routinely reviews the TMF to ensure quality, completeness and inspection readiness ? Coordinates 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 closure ? Assists with identification of and contracting with approved vendors, as necessary ? Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary ? Assists with development and implementation of change orders ? Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently Financials/Reporting ? Develops 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 management ? Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting ? Attends financial review meetings to assist with reconciliation and identification of budget overrun ? Reviews and approves invoices from sites or vendors and to the client Business Development ? Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively. ? May participate in Customer proposal development ? In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings Knowledge/Training ? Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training ? Develops knowledge of current therapeutic environment Qualifications What we’re looking for ? Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred ? Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred. CRO and relevant therapeutic experience preferred ? Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements ? Strong organizational skills ? Strong ability to manage time and work independently ? Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade ? Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment ? High level of competency in English language ? Proficiency with MS Office Applications ? Ability to travel as necessary (up to 25%)