西安招聘

工作职责:

? Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring Roche quality and safety standards, regulations, timelines and budget commitments are met.

? Performs/coordinates protocol and site level feasibility activities. including evaluation of patient population and final site selection (if applicable).

? Provides input into and/or develops study related materials such as Monitoring Plans. Recruitment Plans and Study Newsletters.

? Supports/coordinates the negotiation of site budgets within Fair Market Value (FMV)guidelines. budget plans and provides oversight for site payments per contract, as required.

? Maintains effective and ongoing communication with CSM;supports communication with local study teams and to sites as required.

? Works with global study team and CSMto manage or support the day-to-day activities of the study. including monitoring reports review. problem solving. issue escalation. timely closure of non-productive sites and tracking of safety procedures.

? Supports management of country-level Trial Master File (TMF)and reviews for quality (including translations. as applicable).

? Is responsible for the co-ordination and oversight of local affiliate study level audit/ inspection audit action plan activities.

? Provides feedback to local vendor manager and CSMon CRAs.and local supplier/vendor performance.

? Coordinates study or country communication plan.

任职资格:

? University degree or equivalent; professional qualification preferably in a medical/SCience-related field and experience demonstrating knowledge and understanding of clinical trials.

Monitoring experience is desirable.

Previous experience managing projects is desirable.

? Managing Work - effectively manages self-time and resources to ensure that work is completed efficiently.

? Monitoring Information - sets up ongoing procedures to collect and review information needed to manage an organization or ongoing activities within it.

? Communication - conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others.

泰格医药是行业领先的一体化生物医药研发服务平台，为全球制药和医疗器械行业提供跨越全周期的临床研究创新解决方案。通过全面的服务体系和***的质量标准，我们助力生物医药产业提升研发效率、降低研发风险，确保研究项目高质量交付，加速医药产品市场化进程，履行对行业和患者的承诺。同时，我们也通过覆盖各领域的80多家子公司，打造赋能全产业链的创新生态，推动医疗产业创新和发展。作为全球化的研发平台，泰格医药在全球布局170多个办事处和研发基地，拥有超过8600人的专业团队，覆盖5大洲的51个国家，致力于解决最具挑战的全球健康问题，满足患者的未尽医疗需求，创造社会价值，造福人类健康。