长沙招聘

职位描述：
ROLE SUMMARY
The Director of Clinical Site Management is responsible for ensuring appropriate resources are in place to deliver on key clinical-site management milestones (e.g., start-up, trial conduct, recruitment, close out, etc.) within a designated region/cluster. This role also manages the Regional Clinical Site Leads (RCSL) within their assigned region/cluster and supervises the execution of in country site management and clinical/medical/scientific oversight activities to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practice and Pfizer standards
The Director of Clinical Site Management represents Global Product Development (GPD) as the in country/regional point of contact for the local country/regional medical affairs teams. This role drives the end to end connection of country/regional stakeholders across an asset and collaborates with other stakeholders at the global level to ensure country input into the clinical development, country strategy. This role is also responsible for communication of the future trial portfolio to appropriate country/regional stakeholders.
The Director of Clinical Site Management leads initiatives that support the clinical development environment within their region in order to facilitate Pfizer’s clinical development goals and scientific leadership. For example this role actively manages threats to, or identifies opportunities for, clinical trial conduct through engagement with local clinical development leaders, institutions/networks, and/or regulatory authorities.
The Director of Clinical Site Management provides insights on local/regional trends to facilitate the conduct of clinical trials and where appropriate is responsible for developing analyses and offering options for mitigation (both at the study and site level) on the trial’s conduct.
When assigned, the Director of Clinical Site Management acts as RCSL for a number of clinical trials sites within the region/cluster.


ROLE RESPONSIBILITIES
In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.
Regional Clinical Site Lead management:
？ Lead and coach allocated RCSL within assigned country/region.
？ Oversee job function as described in the RCSL job description and ensure compliance with training requirements.
？ When required, perform joint site visits with RCSL to assess performance.
？ Assign resource to trials and sites ensuring efficient utilization of Regional Clinical Site Lead resources.
？ Manage budget in accordance with financial expectations.
？ Demonstrate leadership in the resolution of site/country/region issues in order to maintain quality and sound investigator site relationships.
？ Establish consistent direction and priorities across assigned countries/region.

Country/Regional Environment & Across Study Management:
？ Responsible for country level input into country selection, pre-feasibility, study design and site selection; when necessary, support and champion existing associated processes. Ensure that feedback on country/site decisions are properly communicated to appropriate stakeholders.
？ Responsible for the oversight of the operational delivery, safety and medical quality of assigned studies performed in the countries across the region/cluster
？ Act as the GPD representative on Regional/Country Medical Councils to ensure transparent communication within relevant Pfizer stakeholders in the region/country.
？ Mitigate systematic deficiencies in clinical trial conduct across sites and countries to improve quality and patient safety in selected investigational sites.
？ Share country/regional issues and trends with stakeholders (e.g.: study/program teams, local medical affairs teams, local CROs, Medical Quality Assurance etc) as needed.
？ Collaborate with local contract organizations (e.g. CRO) as needed to ensure overall delivery, quality, local regulatory and GCP compliance.
？ Working within the directions of a global strategy, build portfolio aligned, investigational sites/network relationships (e.g. INSPIRE networks) and participate in local industry forums to shape performance of ethical clinical research as needed.
？ Shape local clinical research environment by promoting GCP, ethics, regulatory process and investigator training.
？ Practively manage the country/regional relationship with local external stakeholders (investigators, regulators, ethics committees, etc).
？ When required, contribute to area or global GCTE strategy by leading and participating in area or global initiatives.

Clinical/Medical/Scientific Oversight:
？ Support the Regional Clinical Site Lead and study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators and site monitors where required.
？ Demonstrate TA expertise where appropriate.
？ Colleagues with MD equivalent qualification and required experience will take on medical monitoring responsibilities, including participation in 24/7 medical cover and assisting with complex safety, eligibility and other patient or protocol issues.

For activities performed on site for assigned protocols, refer to Regional Clinical Site Lead responsibilities

QUALIFICATIONS
A medical or scientific or technical degree in the healthcare field required.
Extensive knowledge of clinical trial methodologies with proven ability to deliver high quality clinical trial conduct obtained while working with a multi-national pharmaceutical company and/or clinical research organisation
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 and extensive clinical research experience
? PhD/MD or equivalent and extensive clinical research experience
? People management experience

PHYSICAL/MENTAL REQUIREMENTS
In addition to the physical/mental requirements for the RCSL role (see RCSL job description for more details), the Director of Clinical Site Management is expected to show:
？ Ability to lead and manage diverse teams
？ Demonstrated ability to exhibit adaptive risk management and continuous learning capabilities
？ Ability to lead and influence in a matrix environment, capable of driving initiatives across GCTE
？ Demonstrated understanding of HR procedure and policies at global and local level
？ Demonstrated ability to engage with senior stakeholders internal and external to the organization
？ Ability to work effectively with line support functions including finance, HR across the region
？ Ability to both manage the resources required to deliver on organizational commitments and perform specific tasks of the roles managed (in this case the Regional Clinical Site Lead role)
？ Ability to effectively coach and train Regional Clinical Site Leads, including management of escalated issues from sites / investigators, and development of core competencies 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。