上海招聘

工作特色:

1.友善且具挑战性的工作环境

2.具有竞争性薪资

3.海外差旅

工作内容:
1、 负责临床试验的项目管理工作（不分治疗领域），同时兼任重点客户的重点项目及重点中心（主要研究者所在中心）的中心监查工作，确保所有试验严格按照临床试验方案、标准操作程序/内部操作流程和中国法规进行。
2、 对所负责的研究项目进行全面的质量控制与管理，按时完成临床试验在国内的全面启动、执行及结束工作，并及时高效的与项目相关的其他部门人员进行沟通和协调，如医学写作，数据与统计，质量保证人员等等。
3、 负责与申办方及上级领导及时沟通，选定试验中心、研究者并制定试验预算。
4、 项目进行中进行例行质量控制与进展报告。
5、 负责项目相关文件，物资及药品调配，与申办方及时沟通安全，物资，时间点及财务预算的相关内容。
6、 作为公司及客户的主要对外代表及时向研究者（试验医生）传递公司和客户的重要信息，培养并保持与研究者的良好关系。
7、 全面负责本组或项目组CRA及CRA助理的带教培训及日常管理工作。
8、 审阅并签署所有负责项目的例行访视报告与其他TMF文件，审阅并批准与中心的合同文件，协助并建议与申办方的报价与合同文件

资历要求：

（1）基本学历：

医药、临床、卫生及其相关专业，大专及以上学历

（2）基本工作经历：

1、 具有在制药企业或CRO至少三年以上临床研究专员，一年以上项目管理的工作经验。

2、 至少一项国际多中心临床研究参与监查经验，有严格项目的项目管理经验。

3、 全面掌握临床试验管理规范的知识。

4、 熟悉药物研发的全过程，对临床研究的各阶段各部门配合工作完全了解。

（3）特殊技能：

1、 清晰的书面和口头表达能力，善于进行活跃而积极的沟通。

2、 善于与各种不同类型的客户进行交往，并能建立起良好关系的能力。

3、 具备服务意识以及以客户为中心的潜能。

4、 具备优秀的团队组织能力/项目管理技能。

5、 具有优秀的问题解决能力的应急预案管理能力。

6、 具有独力工作的能力，但同时又具有很强的集体意识。

7、 具备中心培训和研究者会议演讲的技能。

8、 熟练应用各种Microsoft office软件，熟悉网络工具的各种应用。

9、 熟悉《药品管理法》、《新药审批办法》、GCP。

10、 熟悉新药研发的基本流程和新药申报的要求。

（4）其他如年龄、性别、婚姻、个性要求：

1、 身体与心理健康，热爱生活。

2、 有良好的人际关系，重视家人与亲友，有领导的能力与亲合力。

3、 热爱并看好本行业，有良好的职业道德和奉献精神。
SCRA/CRA Recruitment
Company: Protech Pharmaservices Corp.
Unit: China operation unit
Location: Shanghai, Beijing, Wuhan, Guangzhou, Chengdu
PPC INTRODUCTION
PPC is one of the prestigious CRO grew up in Taiwan with local affiliates around the Asia-Pacific region in Japan, China, Hong Kong, Singapore and Australia for Asian Study. The company mission is to continuously dedicate to serving the pharmaceutical and biotechnology industry with cost-effective, safe and high standard quality for clinical and non-clinical drug development and shortening the lead time to market.
DESCRIPTION OF THE JOB
1. Clinical Project Management
? Server as key responsible person for the clinical project conducted at the study sites assigned by supervisor.
? Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.
? Evaluate potential sites and provide Project Manager (PM) with recommendations for selection of qualified sites.
? Perform translation of master ICF into local language and develop country/site specific ICF.
? Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.
? Assist PM in start-up meeting.
? Perform and/or assist CRAs in site budget estimation for PM approval, and prepare/manage the clinical trial agreements with investigators/sites.
? Track, manage and control the site budget and expenses within approved budget and in line with the project milestones.
? Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with ICH-GCP, SOPs, local regulations and other applicable project-specific plans.
? Actively track the project status at the sites and provide the management with accurate/complete updates in a timely manner to ensure the project milestones be met.
? Facilitate collection and retention of all essential documents according to ICH-GCP.
? Attend project team meetings.
? Ensure all the processes required for the conduct of a clinical trial are adequately implemented.
? Act as key contact person for the communication between sites and study team.
2. Monitoring
? Prepare, arrange and conduct the training of all aspects of the project for site personnel.
? Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.
? Write a report after each site visit according to the SOP and submit it within required timeframe to the management for review and sign-off.
? Assist the investigator before and during the audit from sponsor and the inspection from regulatory authority.
? Coordinate with the sites to ensure all adverse events as well as follow-up are appropriately reported and reconciled according to applicable SOPs and regulations.
? Identify, analyze and resolve the issues that occur at the sites, and escalate any significant issue to PM and supervisor.
? Assist the site in personnel handovers.
? Assist in project quality management by accompanying junior CRAs during monitoring visits based on the requirements defined in the project specific plan.
? Take on additional responsibilities that may be assigned by PM.
3. Corporate Responsibility
? Adhere to ICH-GCP, company/sponsor SOPs and any applicable regulations.
? Complete all the required SOPs and job-related training in line with the curriculum map.
? Participate in company and external trainings/meetings which are intended to enhance clinical trial related knowledge.
? Conduct the contracted services within the scope of work scope as defined in project contract and notify PM and supervisor of any outstanding issue and work out of the scope.
? Mentor and coach junior CRAs or less experienced co-workers.
? Support the department to conduct co-monitoring visits and implement training programs in line with company objectives.
? Act as a comment provider or an editor for local SOPs.
? Complete the personal performance review with the supervisor within the timeframe required by the company.
? Take on additional responsibilities that may be assigned by supervisor.
REQUIREMENTS OF EDUCATION AND WORK EXPERIENCE
? A 4-year BS (Bachelor of Science) degree. Advanced degree preferred
? > 2 years experience in monitoring
? > 3 years experience in clinical research
? Familiar with on-site monitoring and clinical trials related activities
? Good command of written and spoken English
? Good organization and communication skills

PPC is one of the prestigious CRO grew up in Taiwan with local affiliates around the Asia-Pacific region in Japan, China, Hong Kong, Singapore and Australia for Asian Study. The company mission is to continuously dedicate to serving the pharmaceutical and biotechnology industry with cost-effective, safe and high standard quality for clinical and non-clinical drug development and shortening the lead time to market.

“One Company, World-Class Solution” is more than a mission but our commitment to the serving clients hat keeps us motivated to continually improve in all aspects and exceed our limits.