蚌埠招聘

Position Purpose:

To collaborate in the identification and drive the selection of investigator sites with input from other cross-functional groups. To monitor investigator sites in compliance with Pfizer SOPs, ICH/GCP and local laws so that site performance targets are achieved and that the company’s image with its external customers is enhanced.

Organizational Relationships:

• Reports to the Lead of Site Management

• Dotted line (matrix) report to protocol specific Study Manager

Resources Managed:

Primary Duties (fundamental components of role—both strategic & operational):

Site Selection

Monitoring

• Conduct SDV and ensure clinical trials data are submitted to data management in a timely fashion.

• Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues.

Management of Investigator Sites

• Proactively manage a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met.

• Ensure studies are run in line with ICH/GCP, local laws and Pfizer SOPs and procedures.

• Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements.

• Inform the PI and site staff of all issues.

• Agree and develop corrective and preventative actions with PI and site personnel to close all open issues.

• Responsible for all aspects of site management from collaboration on site selection to study closeout.

• Train site staff on the protocol, protocol amendments and Pfizer processes.

• Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team.

• Interact with health care professionals in a manner, which enhances Pfizer’s credibility with the customer.

Site Close Out

Data Quality

• Ensure that data monitored meets target quality standards.

• Ensure that data is entered into Pfizer systems in a timely manner.

Reporting

• Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.

• Ensure all issues are correctly identified and catalogued.

• Proactively manage issues to appropriate closure.

• Maintain accurate site-level information on corporate clinical trials registry.

Documentation

• Obtain critical information to enable generation of IIP documentation.

• Assist CTA in gathering IIP documentation where required to ensure timely site set up.

• Maintain the SMF and SMF log.

• Ensure ELARA is complete and accurate.

• QC relevant documents in ELARA in a timely manner.

• Generate site monitoring reports.

• Maintain all appropriate monitoring logs.

Training & Education required:

• Life Science/Nursing graduate or equivalent with at least 2 years of Clinical Monitoring/Site Management experience

• Full driving licence

Training and Relevant Experience

• Computer literacy (word processing and spreadsheets)

• Knowledge of ICH/GCP, relevant international and local regulations relating to Clinical Research

Technical Competencies

Competency Detail / Comments (specific skills, etc.)

Quality requirements Demonstrated knowledge of quality and regulatory requirements across a range of different countries.

Drug development process Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment.

Scientific/technical/administrative excellence Demonstrated success in prior scientific/technical/administrative management roles.

SOP Compliance Maintain knowledge and expertise on all relevant SOPs.

Communication and presentation skills Ability to communicate effectively and appropriately with internal and external stakeholders.

Administrative excellence Attention to detail evident in a disciplined approach to document training, adherence to SOPs, forecast to spend tracking, metrics, etc.

Organisational skills • Works independently. Receives instruction primarily on unusual situations.

• Ability to organize tasks, time and priorities of self and others; ability to multi-task.

Behavioral Competencies

Competency Detail / Comments (specific skills, etc.)

Understanding stakeholder needs Seeks to develop an integrated view of key colleague issues to shape decisions and strategy development.

Achieving quality and excellence Looks across and outside the organization for better ways of working – receptive/willing to others ways of thinking.

Initiating and Implementing change Proactively manages change by identifying opportunities and coaching self and others through change.

Interpersonal communications Displays sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organization.

Influencing • Demonstrated ability to introduce new ideas and get them implemented.

• Effectively overcoming barriers encountered during the implementation of new processes and systems.

Teamwork Is visible and well recognized across the Area for promoting collaboration across functional and geographic boundaries.

Learning organisation Seeks to clarify feedback non defensively to understand required improvement.

Customer Focus Identifies and builds effective relationships with customers and other stakeholders.

接收简历邮箱为：job-south.china@pfizer.com

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***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“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
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.