Study Manager 北京

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  • 招若干人
  • 11-09 发布

职位描述

职位描述： 工作职责： Primary Duties:Across Entire Study:o Actively manages the activities and deliverables of all study partners (e.g. RU/BU, Investigator sites, site management functional lines, Clinical Trial Support and Compliance, Pharm Sci, GCDS, CRO/SMOs, vendors) to ensure timely delivery of quality data on multiple studies.o Effectively manages and leads external vendors to deliver key clinical operations milestones for outsourced studies.o Oversees site management functional lines to ensure that protocol and monitoring plan are consistently and appropriately implemented across investigator sites. Ensure the sites and site management functional lines are provided with the information to effectively contribute to the study. o Proactively identify and resolve study operations-related issues as they arise.o Responsible for ensuring that the operational aspects of a clinical study meet time, quality & cost targets consistent with the Clinical Development Plan and China new product development strategy. o Responsible for ensuring that studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; Responsible for inspection readiness for all aspects of the study conduct.o Assist Clinical Project Manager to develop project plans and implement resource strategies to achieve RU/BU project goals, including contingency planning and risk mitigation strategies, to ensure successful delivery of study goals.o Share best practices across the organization to ensure cross-line standardization. o Support the efficient implementation and utilization of globally agreed, processes, technologies and strategies (e.g. OC-RDC, Datalabs, IMPALA, etc.) to ensure consistent processes are used across studies.Study Start-upProtocol Developmento Provides input to the core protocol elements (CPE) (as early as the concept stage, if appropriate) to ensure operational feasibility. o Responsible for conducting the protocol feasibility prior to finalization of the CPEs, as appropriate. o Provides input to the study management components of the protocol; o Produces study level ICD, as appropriate.Budgeto Provide input to the generation of investigator grant budgets at the study level (identify required budget components).o Initiate, review and ensure approval of the study start-up budget, including per subject and ancillary investigator costs, and Clinical Trial Budget (or MPA).Data Management/GCDS Interactionso Partner with GCDS to ensure set up of data capture tools (CRFs, EDC system, diary cards, questionnaires, translations etc.) to ensure completion within project deliverable timelines.o Overall responsible for ensuring the study has efficient and effective data flows (for all types of study data, including SAEs, endpoints, patient diaries, lab data, etc).Subject Recruitment/Country Allocation/Site Selection/Start-up (as appropriate)o Conducts study level allocation including country and study level feasibility assessments to ensure appropriate site selection in China.o Develops study level recruitment/retention strategy/plan; oversee implementation of plan, including site-level plans, recruitment/retention tools, and advertising materials.o Oversees sites and site management to ensure timely site selection and site readiness (Clinical Site Agreements, Ethics Committee approvals and regulatory documentation.)Training/Investigator Meeting (as appropriate)o Develops the Monitoring Plan; ensure sites and site management functional lines are trained on Protocol-Specific aspects of the Study Monitoring Plan.o Responsible for working with Clinician to ensure that site management functional lines are provided with appropriate training in both the protocol and therapeutic area.o Drives and/or contributes to investigator meeting strategy/agenda and responsible for overseeing implementation by the project team; review meeting objectives/materials.o Facilitates and presents at investigator meetings, as required by project team.Drug Supplyo Collaborates with CPM and Supply Chain Lead to develop and complete of the Request for Clinical Supplies.o Works with the Supply Chain Lead to ensure that clinical trial drug supplies are ordered, produced, labeled and supplied in a timely manner.Communications and Tracking Deliverableso Tracks progress to ensure all essential study materials, equipment and documentation are in place for study start (e.g., ethics and regulatory approval, budget, drug supplies, data collection tools). o Communicates status to Clinical Project Manager and project team as appropriate.Clinical Study ConductSubject Recruitment/Retentiono Manages protocol-level subject recruitment and retention and take action to ensure targets are met.Quality & Compliance Managemento Periodically review protocol deviations and collaborate with clinicians to manage protocol deviations according to Pfizer SOP.o Works closely with project team to ensure data quality requirements are agreed to and met, prior to reporting.o Performs required activities to ensure quality and completeness of Trial Master File and any additional regulatory documentation.o Works with quality assurance line to establish appropriate QC, audit and inspection plans. Serves as central point of contact for site and sponsor audits. Supports the writing of appropriate audit responses and ensures actions are completed.Data Flow Managemento Partners with GCDS and site management functional lines to ensure timely retrieval and database entry of CRFs and other clinical study data and the distribution and resolution of data queries.o Coordinates endpoint collection, reconciliation and adjudication, when required.o Coordinates data collection and cleaning for interim data locks (e.g., DSMBs, Planned interim analysis, Final Safety Updates, etc)CRO/Vendor Managemento Supports project team in the effective management of external vendors including SMOs and CROs.Budgeto Compiles components of protocol level budget.o Approve up front or initial payments to investigators and vendors.Drug Supplyo Works with Supply Chain Lead to ensure drug supply (including resupply) process timelines, risks and issues are handled in a timely manner.Communications and Tracking Deliverableso Uses the production and tracking of metrics as a tool to monitor report on and actively manage the delivery of project team goals.o Monitors cross-site performance and raise issues with sites and site management functional lines.o Responsible for distribution of information regarding the study at the protocol level to site management functional lines and investigational sites as appropriate.o Works with site management functional lines to ensure investigational sites are fully informed of all study related information in a timely manner.Clinical Study Close-outo In close partnership with the sites and site management functional lines to ensure site closeout activities are completed.o Responsible for the collection and consolidation of the Protocol Deviation Logs.o Accountable for study close out; support GCDS in database lock and release activities, ensuring all timelines and quality goals are met.o Contributes information regarding study conduct, as required, to ensure effective and timely study reporting. Participates in review of study report, as appropriate.Training & Education Preferred:o Minimum of BS/BA in a biomedical discipline or equivalent education/training is requiredo At least 5 years in clinical practiceso Good working knowledge of Chinese/ICH GCP guidelines and Pfizer SOPso Knowledge on drug development process and country regulatory environmento Experience with clinical research methodology (e.g., study design, study monitoring and data analysis). Prior study management and/or study coordination experience preferred. Demonstrated effectiveness in working in a multidisciplinary, matrix team situation. o Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization. Prior Experience Preferredo Advanced education and/or training/experience desirable. · 任职资格： Technical Competencies:Competency Detail/Comments (specific skills, etc.)o Scientific and drug development expertiseo Clinical study expertise§ Problem solving/Decision Making§ Organizational skills§ Communication skillso Project/process managemento Administrative excellence§ Clinical/Scientific aptitudeo Technology managemento Budget / expense management o Understanding of scientific/clinical principles, and ability to work across different therapeutic areas. Knowledge of working with complex and novel emerging technologies, and interpret and incorporate them within the context of a clinical trial.o Extensive knowledge of clinical development process including in depth knowledge and understanding of the principles of GCPo Ability to understand and influence Site Investigators/Key Opinion Leaders on non-medical related issueso Working knowledge of the principles and concepts of other disciplineso Works independently. Receives instruction primarily on unusual situationso Ability to make complex decisions that require choosing between multiple options and have the potential to impact the delivery of the program/project and resource on the program/project.o Ability to work in ambiguous situations within the team to identify and resolve complex problems.o Ability to organize tasks, time and priorities of self and others; ability to multi-task.o Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally.o Ability to write scientific documents and to be able to ‘translate’ these into documents used for operationalizing clinical studies.o Ability to manage studies and processes to agreed quality and timelineso Knowledge of the clinical development process, understand concepts and principles of study design, and application to manage and run studieso Attention to detail evident in a disciplined approach to document maintenance and managemento Extensive depth and breadth of knowledge of systems/processes related to all aspects of study conduct to enable crisp study delivery.o Knowledge/understanding of technologies to support data acquisition including EDC and data validationo Understands and has ability to efficiently manage budgetso Consistently utilizes industry benchmarking and performance dataBehavioral Competencies:Competency Detail/Comments (specific skills, etc.)o Collaborative, supportiveo Innovationo Influencingo Networking and Alliance Buildingo Learning Organizationo Flexibility 职能类别： 其他

联系方式

北京

公司信息

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球最大的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。 我们的目标是“ ”。我们的使命是“ ”。 2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。 目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。 在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。 辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。 辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。 辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。 At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.

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