长沙招聘

工作职责:

? Has full accountability and oversight for all assigned studies at regional/country level (Global and local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans(e.g. timelines, budget, resource, risk and quality plans) in the appropriate Roche planning system).

? Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.

? Leads local study teams, represents Country/Region Clinical Operations at the global SMT, and provides Global Teams with feedback From an Affiliate perspective (Global).

? Plans and executes country study goals and commitments, and ensures compliance to relevant processes.

? May serve as global Country Study Representative (gCSR), as part of global study team.

? Coaches and provides support to responsible study team members.

? Provides study oversight,leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CROstaff performance as required.

? Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.

? Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.

? Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and Future Roche studies.

? Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.

任职资格:

? University degree or equivalent; preferably in a medical/science-related field and extensive experience and expertise in clinical research/development or related industry. Extensive experience in clinical trial project management.

? Decision Making - identifies and understands problems and opportunities by gathering, analysing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints, and optimizes probable consequences.

? Establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines, and leveraging resources.

? 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。