梧州招聘

? Recognize potential challenge within the protocol and operational aspects of the trial and escalate to manager as appropriate/decide on appropriate action.
? Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel
? Support / independently lead trial feasibility and CPO patient commitments in cooperation with the relevant line units: ensure two-way feedback on feasibility between global team and country.
? In liaison with the global clinical team, assist in the development of/independently lead strategic local trial execution plan and timeline commitments for a country/cluster
? Work with CRA group head to plan resource for assigned clinical trial activities.
? Coordinates and manages the site selection process in collaboration with the necessary line units
? Ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions.
? Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents.
? Ensure sites are prepared for Ready to Initiate Site (checkpoint) by monitoring the status of clinical trial supply delivery.
? Ensure that all documentation in place for initial and subsequent drug release in collaboration with the local Qualified Person.
? Provide training as needed for monitors and any other activities that support site readiness to recruit.
? Ensure documentation of training is archived appropriately.
? Conduct local investigator meetings as needed.
? Drive the conduct of the trial, track and oversee progress and status.
? Ensure all operational aspects are on schedule.
? Oversee local clinical team activities to achieve trial timelines and quality execution according to Novartis standards and local and international regulations.
? Appropriately escalates issues in a timely manner and ensures resolution. Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics
? Lead and chair local study team meetings, attend and participate in global clinical trial team meetings
? Track trial budget with appropriate trial budget responsible in country. Oversee TCF preparation and submission to COM in collaboration with the TCF specialist in the country
? Accountable for coordinating data management activities through the local trial team.
? Communicate with monitors/sites to ensure timely resolution of data issues.
? Keep oversight of country level data including lab values time to date entry at sites, screen failure reasons, discontinuations rates, patient profiles, and proactively identify data entry issues to mitigate queries
? Accountable to keep reporting systems up to date: Impact/ClinAdmin, TMF, CREDI... throughout trial conduct
? Ensure that all trial close-out activities are performed, in close cooperation with field monitors and clinical trial head.
? Oversee local vendor selection and performance as needed. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required
? Facilitate internal audits and HA inspections as required.
? Review field monitor's visit reports.
? Conduct co-monitoring visit to field monitors from project perspective to ensure trial's quality and milestone achievement where needed.
? Mentor/coach monitors, clinical trial coordinators/administrators and sites as required; Assess monitor's competencies and skills on a regular basis and maintain a feedback to CRA group head.
? Expected to manage more complex trials as locally defined
? May be involved with special projects and workstreams

北京诺华制药有限公司开发、生产和销售治疗多种疾病的创新处方药，涵盖的疾病领域包括：心血管、内分泌、肿瘤、抗感染、风湿疼痛及骨质疏松、移植免疫、中枢神经以及眼科。北京诺华制药曾获得“***雇主”和“最负社会责任的企业”等殊荣。

“诺华”中文取意“承诺中华”，即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年，总部设在北京，隶属于瑞士诺华公司。

诺华公司致力于为患者及社会提供创新医药保健解决方案，以满足其日益变化的健康需求。2011年，集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元（去除减值及摊销后为92亿美元）。诺华集团总部位于瑞士巴塞尔，业务遍及全球140多个国家和地区，拥有124,000位全职员工。诺华集团立足在中国的长期发展，重要战略投资包括位于上海的综合性生物医学研发中心，以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息，敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。