长沙招聘

职位描述：
ROLE SUMMARY
The Regional Clinical Site Lead 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 responsibilities
The Regional Clinical Site Lead 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 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 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 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 is recognized and acts as a Subject Matter Expert for a category or global processes within the GCTE organization.

ROLE RESPONSIBILITIES
Responsible 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 delivery
Study 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 Management

Regional Clinical Site Lead management:
May have delegated responsibility from the Director of Clinical Site Management (or Sr. RCSLs)

QUALIFICATIONS
A scientific or technical degree in the healthcare field or an MD / MD equivalent degree along with:
Extensive knowledge of clinical trial methodologies
Must 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

PHYSICAL/MENTAL REQUIREMENTS
？ 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
？ Availability to travel within the region and/or globally as required 举报 分享

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。