Study Manager (Phase I) 北京

月薪： 1.5-2.5万/月

该公司所有职位
  • 8-9年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 弹性工作
  • 定期体检
  • 餐饮补贴
  • 通讯补贴
  • 绩效奖金
  • 年终奖金
  • 交通补贴

职位描述

职位描述： Major Tasks and Responsibilities of Position?Manages and is responsible for all activities related to complex phase I and extended phase I/IIa clinical trials from the approved study concept to the clinical study report.? Develops and Leads a Study team, manages all Study Team activities as defined per SOPs/OIs and ensures the organization of regular Study Team meetings. Develops and manages budget, timelines and quality of the study and its deliverables. Responsible for forecasting and tracking of study costs. Ensuring all relevant IT-systems are updated with current and accurate information (e.g. IMPACT) Responsible for training and oversight of CROs to ensure compliance with timelines and budget.?Together with OPL and ECL/CPL and with guidance of the Head Study Management China is responsible for selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.), developing the total external study budget and accountable for providing monthly and yearly estimates, tracking study budget, initiating payments, providing monthly information to controlling, OPL, ECL/CPL, identifying budget/estimate issues and proactively developing a plan for resolving study finance issues.?Writes protocols and amendments in collaboration with study team members. Responsible for study specific feasibility and site selection to meet study enrollment and timelines. Responsible for timely delivery of all start up activities e.g. CRO selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight.?Tracks and compiles patient enrollment, data cleaning progress and overall study progress and ensures study timelines are met. Develops appropriate study related training for monitors and site personnel according to GCP and company standard. Ensures accurate data collection, protocol adherence, patient safety, PK, PD, biopsy sample integrity and GCP compliance. Escalates severe deviations to a key parameter (i.e. recruitment, timelines, patient safety, protocol compliance, data collection/cleaning, budget) after discussing and in alignment with the Study Team to OPL and /or ECL/CPL and functional manager.?Point of contact for managing/answering questions related to trial procedures and patients’ eligibility?Ensures clinical trial registry and results posting according to global requirements and guidelines, manages the study insurance according to required timelines?Ensures set-up, maintenance and Quality Control of the study Trial Master File (TMF)?Conducts lesson learned at any point in time when requested by management or any Study Team member and mandatory at study closure. 职能类别： 生物工程/生物制药

联系方式

北京市朝阳区建国路91号金地中心B座917

公司信息

RPS Inc. is a next generation global CRO, headquartered in the United States with the operations in 45 countries throughout Americas (US, Canada, Latin America), EMEA and Asia Pacific regions. RPS provides comprehensive global Phase 1-4 clinical development solutions to the pharmaceutical, biotechnology and medical device industries. By combining an experienced clinical research operations infrastructure with the industry’s largest resourcing engines, RPS is uniquely positioned to offer our Clients both integrated and full service global outsourcing solutions. These solutions are powered by highly experienced and seasoned study teams providing innovative, cost-effective and high quality services. RPS Asia Pacific Headquarters is located in Beijing, China and we have operations in 11 Countries in Asia Pacific region. With the rapid organic expansion of RPS in China & Asia Pacific, we are continuously looking for the experienced industry talents to join us. Our specialized staff of consultants is eager to discuss your career plans. Tell us about yourself experience, so the appropriate consultant can contact you. RPS is sensitive to your daily responsibilities. Tell us EXACTLY how to contact you and we will. For your convenience, you can also submit your resume. We look forward to discussing the opportunities and benefits of employment with RPS! For more information, please visit our website www.rpsweb.com.

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