高级地区经理 (职位编号：10189/7811/9826) 广州

月薪： 1-1.5万/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 英语良好
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 专业培训
  • 绩效奖金
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

职位描述： YOUR TASKS AND RESPONSIBILITIES1. Directly manages 8-12 insourced staff combined of Country Lead Monitors, Sr Site managers and Site Managers. Assures hiring, training, development, and compensation are in line with talent and job expectations. Through effective management and oversight of direct reports, the Manager of Monitoring ensures quality and compliance as well as ensuring country’s objectives are met. Provides expertise and strong leadership and management to insourced staff and maintains a motivated and competent staff, embedded into the Global Site Management country organization.2. Ensure projects/studies are resourced appropriately by allocating or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of assigned insourced staff. These activities are done in close alignment with Country Head and peers.3. Accountable for all operational activities related to global and country procedures applied in the site management of applicable Phase I and all Phase II-IV clinical trials. This includes country feasibility, site selection, site initiation, patient enrollment and data cleaning processes assigned insourced staff is responsible for. The GSM Manager of Monitoring assures that each assigned staff member delivers high quality study data required to support ethical standards and regulatory submissions in compliance with global operating standards.4. Responsible for managing costs associated with assigned insourced staff and participates in the Country Head of Site Management’s preparation and tracking of the insourced budget. Responsible for tracking insourced costs appropriately and provides estimates and accruals to Country Head on a monthly basis.5. Quality Oversight - Oversees Corrective Actions / Preventive Actions (CAPAs) of assigned insourced staff to ensure timely and sufficient resolution. Conducts Monitoring Oversight Visits for each Site Manager as GSM expectations to ensure Site Managers are trained appropriately and to identify potential training or development needs. Participates in Audit Review Meetings and reviews all responses to audit findings prior to submission. Collaborates effectively with vendors providing insourced resources to develop and implement training and development plan in a timely manner based on any deficiencies found or areas for improvement.6. Continuously and proactively identifies and proposes solutions for process improvement opportunities to Country Head GSM, and communicates best practices to entire monitoring staff. Participates as member of Expert Working Groups and provides feedback on SOP updates.7. Coordinates responses of audits with Global Quality Management. Proactively identifies actions to be taken at the country level to improve upon audit and inspection findings. Supports Country Head with follow-up of all Regulatory Inspections, Regulatory concerns related to investigator integrity, GCP and the veracity of all clinical data in NDA, CTD, PLA, SNDA and IND submissions.8. Contributes to delivering Training programs developed by GCDO ICH-GCP Training as well as coordinating all job-specific training needs for insourced CLMs, Sr Site managers, and Site managers. Requires thorough understanding of global and local processes, Global Drug Development and associated Global Standard Operating procedures (SOPs).9. Contributes to development of country clinical investigator network to support the portfolio needs for clinical trials. Collaborates with Medical Science Liaison management to cultivate and enhance clinical investigator relationships to support business strategyWHO YOU AREThe incumbent is a highly successful candidate with extensive professional and academic experience. Key competencies needed by the candidate include the following:? Bachelor’s degree (or equivalent) with 8 years’ relevant healthcare experience including 4-6 years’ relevant clinical development or clinical operations experience? In-depth knowledge of clinical development and drug development process, global clinical development processes, ICH-GCP, applicable legal, compliance and regulatory requirements? Leadership, motivational, and collaborative skills are critical. Ability to lead staff in changing times as well as strong interpersonal skills in the management of people in a global environment. Able to collaborate effectively with external vendors and partners in the development and retention of a high-performing insources staff? Administrative, financial, and technical skills are required, as well as effective verbal and written English communication skills in relation to both internal and external colleagues? Able to work effectively within a multi-cultural, global, matrix organization 职能类别： 医药销售经理/主管

联系方式

广州

公司信息

拜耳医药保健是拜耳集团的子集团，是世界十大医药企业之一，也是医药保健及医疗产品行业世界领先的创新企业之一，全球拥有员工53100人，总部位于德国的勒沃库森。拜耳医药保健致力于研究开发、生产和销售用于预防、诊断和治疗疾病的原研产品。2008年，拜耳医药保健全球销售额达154.07亿欧元，其中研发经费为17.42亿欧元，占拜耳集团总研发投入的66%。 拜耳医药保健和中国的渊源可以追溯到20世纪初期。早在1936年，拜耳就在中国成立第一个生产公司－拜耳医药公司，生产一系列产品。目前，拜耳医药保健有限公司在中国拥有员工约4000人，总部位于北京。在北京、广州、成都、江苏设有工厂，致力于拜耳先灵医药、保健消费品、糖尿病保健及动物保健四大业务。其中，拜耳先灵医药是拜耳医药保健有限公司下属最大业务部门，是拜耳医药保健的处方药部和先灵（广州）药业有限公司合并而成，业务遍及70多个城市，产品线覆盖普药业务、女性健康、特殊治疗以及影像诊断四个领域。2008年7月，拜耳医药保健的保健消费品部收购了东盛盖天力西药非处方药业务。 2008年，拜耳医药保健完成了投资达2.2亿余元人民币的北京生产厂的扩建。 北京工厂新建的生产线将采用目前中国乃至亚洲地区最为先进的设备，产能是以前的4倍。除了硬件系统投资，拜耳医药保健北京工厂还引入先进的软件管理系统，包括全自动称重系统、物流管理系统等将使得药品的品质更上一层楼。 拜耳医药保健有限公司在中国的发展蒸蒸日上。 在业务发展的同时，拜耳医药保健始终不忘社会责任，积极与社会各方面进行深入合作。2008年11月，与中国就业促进会合作开展了“农业富余劳动力健康安全转移就业培训项目”，计划在3年内对3万名农业富余劳动力免费提供健康安全转移就业培训。尽管目前处在全球经济困难期，我们仍将继续关注那些需要帮助的社会弱势人群。 为促进并提高中西部地区县级医院的整体医疗服务技术水平，2008年拜耳医药保健和卫生部合作的“走进西部”万名县级医院医师培训项目成功开展。目前已在甘肃、青海、宁夏、云南四省进行了６期培训工作，已有３６３人参加了培训。２００９年“走进西部”项目还将延伸到江西、广西、陕西、贵州、新疆等五个省份，共计划培训１１２２名医生。 2009年初，拜耳医药保健新的研发中心将在北京落户，成为其全球架构中的第四大研发中心。这一举措不仅表明了我们在中国长期发展的决心和信心，并为拜耳医药保健成为亚洲制药领域的领导者提供坚实基础。

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