BIOSAMPLE OPERATIONS MANAGER 北京

月薪： 0.8-1.6万/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 出国机会
  • 专业培训
  • 绩效奖金
  • 年终奖金
  • 定期体检
  • 餐饮补贴
  • 通讯补贴

职位描述

职位描述： 1.Position purpose?The Biosample Operations Manager plans and coordinates all operational activities for the collection, handling, storage and delivery of biomarker, pharmacogenetic, immunogenicity and pharmacokinetic samples (in following: “biosamples”) within Phase I to III clinical study, while being simultaneous assigned to multiple studies.?The Biosample Operations Manager provides sound biosample management expertise to the study management team and is accountable for ensuring that biosamples collected are of optimal analyzable quality and are collected in adherence to the highest standards and informed consent.?The Biosample Operations Manager is responsible for training of investigational sites on all topics regarding biosample handling.?The Biosample Operations Manager is the primary interface for operational activities between the study management team and laboratories performing biosample analysis and is the first point of contact for the monitors regarding all aspects of biosample handling.2.Geographical scope?Global, with focus on Asia and particularly China3.Responsibilities of position?Plans, organizes, monitors and enforces the collection, processing, storage and logistics of Biosample within a study?Accountable for preparation of study related documents (biosample management plan, laboratory manual, sample handling sheets etc.) as well as development of shipment schedules, sampling and storage requirements in close collaboration with central and analytical laboratories.?Responsible for handling of samples according to protocol, SOPs, GCP and ICH-guidelines.?Initiates the contracts with the biosample management central laboratory and will be responsible for forecasting the cost and tracking the budget of these contracts in the respective studies.?Training of monitors, study nurses and investigators.?Supports the study team with the submission to IRBs and ECs and responds to IRB/EC requests.?Tracking, monitoring and documentation of biosampling activities.4.Qualifications (Education, skills, experiences and personal characteristics necessary for success in this position)?Post-graduate degree in Life Sciences (MSc, PhD).?>3 years experience in clinical research, with detailed understanding of clinical development processes (e.g. study management or CRA).?Detailed knowledge of the ethical, legal and logistic requirements of obtaining and processing human blood and tissue samples.?Proven clinical development experience of working in teams running clinical studies (study management), monitoring clinical studies or experience of working in clinical studies at an investigator site.?Good knowledge of BM and PK analytical processes.?Proven ability to plan, organize and manage multiple projects under pressure?Proven ability to successfully achieve results within a multi-cultural and geographically diverse team?Effective communication and negotiation skills in English 职能类别： 医药技术研发管理人员

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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