R&D-Regional Clinical Site Lead II招聘_辉瑞制药有限公司最新招聘信息-猎才医药网

职位描述

职位描述：工作职责The Regional Clinical Site Lead II is responsible for in country site management and clinical/medical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards. Typically responsible for moderate to high risk / business critical studies and may have asset level responsibilitiesThe Regional Clinical Site Lead II role is accountable for managing investigator site relationships to ensure effective delivery of clinical trials (e.g. study start up, enrollment, database release), to safeguard the quality of investigator sites (e.g. site health, patient safety) and to maintain investigator and study coordinator engagement and satisfaction, particularly with INSPIRE sites.The Regional Clinical Site Lead II role is the local expert for the assigned clinical trials and brings that expertise to support the investigator site, which includes the investigator, study coordinator, pharmacist etc., and to oversee and support the site monitor in the conduct of clinical trials. This role is responsible for the resolution of protocol-related issues at the local level.The Regional Clinical Site Lead II is the in country Global Product Development interface with the local country/regional medical affairs teams. The RCSLII has a proven record as an effective interface with the study team and is the conduit from the study team back to the regional clinical site management function. This role supports the Study Team by providing regional / country insights and updates on the evolving local clinical development environment as well as cross-site insights regarding study performance and has demonstrated a value added contribution to the success of study teams.The Regional Clinical Site Lead II demonstrates leadership within the local clinical development environment with a goal to enhance our reputation in scientific leadership. The role is key in providing cross study, and cross site insights into the Clinical Development portfolio at the country/regional level.The Regional Clinical Site Lead II is recognized and acts as a Subject Matter Expert for a category or global processes within the GCTE organization.ResponsibilityResponsible for country site management and clinical/medical/scientific oversight for assigned studies:Site Management & Delivery:?Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleague, and with input from external clinical experts as required.?Provide recommendations on potential sites and provide targeted follow up with key sites as required. Influence the study teams in the selection of INSPIRE sites?Oversee and support study start up activities at the country level, including review of key documents (eg local Informed Consent Document template), and providing support to address regulatory and/or ethics committee questions.?Oversee and support study start up activities at the site level, including management of emerging issues that may compromise time to site activation.?Provide enrollment support and ensure progress by responding to start-up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site / country level?Lead effective site recruitment planning and implementation of plans at the country and site level, consistent with global plan and local specificities?Support database release as needed.Clinical/Medical/Scientific Oversight:Be proactive in ensuring overall site quality, regulatory and GCP compliance.？Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators and site monitors.？Provide protocol training to, and address protocol related questions from, the investigator site staff, site monitor and other RCSLs when required. This may include attendance at investigator meeting and/or site initiation visits and should involve discussions on known/anticipated operational and clinical risks？Create and manage (the study oversight plan) and mitigate for known/anticipated risks proactively？Monitor site performance using appropriate tools and resources (e.g. metrics, site health, Risk Based Monitoring signals etc) and take appropriate targeted action. Conducts risk assessments to identify actions for mitigation and control across studies？Apply knowledge of data and analytics to target site, study and asset level actions for mitigation and control. Demonstrates us of these data to enhance quality and accelerate study delivery.？Conduct and report oversight activities, both remote and onsite visits according to Pfizer standards.？Proactively identify, manage and escalate site issues.？Help to address Significant Quality Events or other quality issues at patient and/or site level.？Ensure resolution of investigator site issues in order to maintain sound investigator relations.？Communicate with investigators and study coordinators on a regular basis to build and maintain productive relationships and support investigator engagement through medical and scientific discussion.？Provide support for site audits/inspections as needed.？Maintain a thorough knowledge of assigned protocols.？Demonstrate TA/Category expertise where appropriate.？Colleagues with MD equivalent qualification and required experience will take on medical monitoring responsibilities, including participation in 24/7 medical cover, being the local point of contact for medical issues and assisting with complex safety, eligibility and other patient or protocol issues.？Demonstrates the learning culture by ensuring preventive actions are shared across assets in the portfolio to drive accelerated drug delivery？Systematically applies site level learnings from risk identification, mitigation and control, across the trial and beyond (e.g., on asset level)？Drives continuous improvement initiatives and implementation within GCTE and across Clinical Sciences & Operations to ensure successful trial deliveryStudy Team Interface:?Interface with the study team as needed and act as representative of the RCSL function. Recognized historically as a critical contributor to the success of a study team?Champion and ensure update of existing tools / processes related to clinical site selection and management?As needed, facilitate the exchange of information to / from the study team on study progress and impact of local clinical development environment on study / site?Provide regional and cross-regional insights on study-site performance and trends to / from the study team?Represents RCSL organisation on country level and/or acts as delegate for the Director of Clinical Site ManagementRegional Clinical Site Lead management:May have delegated responsibility from the Director of Clinical Site Management (or Sr. RCSLs)任职资格A scientific or technical degree in the healthcare field or an MD / MD equivalent degree along with:Extensive knowledge of clinical trial methodologiesMust be fluent in English. Multi language capabilities are an advantage in this role.In general, candidates for this job would hold the following levels of education/ experience:?BS/BSc/MS/MSc or equivalent with demonstrated clinical research experience and a track record of delivery?PhD/MD or equivalent with demonstrated clinical research experience and a track record of delivery？Demonstrated knowledge of clinical research and development processes and ability to gain command of process details？Demonstrated knowledge of global and local regulatory requirements？Demonstrated ability to influence local clinical trial environment？Demonstrated understanding of key operational elements of clinical research (e.g., site selection, monitoring, data acquisition and cleaning, reporting, etc.)？Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)？Demonstrated ability to lead, participate and support sponsor regulatory interactions/inspections？Demonstrated knowledge of the processes around protocol design and feasibility assessment？Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery？Demonstrated networking & relationship building skills？Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial？Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation and to inform study/asset level decisions？Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization 职能类别：临床研究员

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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