更新于 今天
职位描述
SSUSTUDY STARTUP药品临床研究新药Ⅰ期Ⅱ期Ⅲ期
Company Description
PSI is a leading Contract Research Organization with 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
PSI is a leading Contract Research Organization with 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
SCOPE OF RESPONSIBILITIES
1. Core responsibilities （the scope of responsibilities may vary and is dependent on project allocations and study startup process specifics in the country/region）
1.1. The Study Startup Manager leads study startup in 1 to 3 assigned countries on projects within a region starting from project start until site activation.
1.2. Ensures that startup deliverables in assigned countries are met.
1.3. Participates in development and update of project/country startup and site activation timelines.
1.4. Acts as a primary or secondary contact for client and vendors for startup matters within assigned countries. 1.5. Reviews the quality metrics and reports quality issues.
1.6. Ensures startup team compliance with project-specific training matrix and trains project team on Study Startup processes.
SCOPE OF RESPONSIBILITIES
1. Core responsibilities （the scope of responsibilities may vary and is dependent on project allocations and study startup process specifics in the country/region）
1.1. The Study Startup Manager leads study startup in 1 to 3 assigned countries on projects within a region starting from project start until site activation.
1.2. Ensures that startup deliverables in assigned countries are met.
1.3. Participates in development and update of project/country startup and site activation timelines.
1.4. Acts as a primary or secondary contact for client and vendors for startup matters within assigned countries. 1.5. Reviews the quality metrics and reports quality issues.
1.6. Ensures startup team compliance with project-specific training matrix and trains project team on Study Startup processes.
2. Resource Management & Training
2.1. Assists with Study Startup resource allocation in the assigned country(-ies).
2.2. Develops training materials, delivers training and provides methodological support to operational staff in within the assigned country(-ies).
2.3. Mentors and coaches assigned department staff in the country.
2.4. Takes up line management responsibilities for local Study Startup team members within assigned country(-ies).
2.1. Assists with Study Startup resource allocation in the assigned country(-ies).
2.2. Develops training materials, delivers training and provides methodological support to operational staff in within the assigned country(-ies).
2.3. Mentors and coaches assigned department staff in the country.
2.4. Takes up line management responsibilities for local Study Startup team members within assigned country(-ies).
3. Quality Assurance and Process Improvement
3.1. Identifies and escalates country-specific startup operational issues regional leads.
3.2. In cooperation with the Line Manager, monitors startup key performance indicators for projects in startup on a country level and implements improvement plans.
3.3. Develops and updates manuals, local instructions, and user guides relevant to Study Startup activities within the assigned country and provides local expertise and best practices to other PSI functions and clients.
3.1. Identifies and escalates country-specific startup operational issues regional leads.
3.2. In cooperation with the Line Manager, monitors startup key performance indicators for projects in startup on a country level and implements improvement plans.
3.3. Develops and updates manuals, local instructions, and user guides relevant to Study Startup activities within the assigned country and provides local expertise and best practices to other PSI functions and clients.
Qualifications
1. Bachelor's or above degree in Life Sciences or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities.
2. At least 7 years of Study Startup experience in the country/region and over 3 years of experience in a Lead/Line Manager role.
3. Communication, presentation, and customer-service skills.
4. Team building, leadership and organizational skills.
5. Full working proficiency in English and Chinese.
6. Proficiency in MS Office applications, including MS Project.
1. Bachelor's or above degree in Life Sciences or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities.
2. At least 7 years of Study Startup experience in the country/region and over 3 years of experience in a Lead/Line Manager role.
3. Communication, presentation, and customer-service skills.
4. Team building, leadership and organizational skills.
5. Full working proficiency in English and Chinese.
6. Proficiency in MS Office applications, including MS Project.
工作地点
上海黄浦区腾飞元创大厦
公司信息
辟埃赛医药科技(上海)有限公司
不需要融资 · 20-99人 · 医药研发/生产外包（CXO）
已审核
公司介绍
PSI is a leading full-service global Contract Research Organization providing a wide range of clinical trial services to the pharmaceutical and biotechnology industry, mainly for the development of clinical drugs. PSI has 2,200+ employees and 40+ affiliates in Europe, North and South America, Asia Pacific and South Africa. PSI是一家提供全方位服务的全球临床试验项目承包商，为制药和生物技术行业提供广泛的临床试验服务，以帮助临床药物的开发。PSI在欧洲、北美和南美、亚太和南非拥有2200多名员工和40多家分支机构。
工商信息
企业名称 辟埃赛医药科技（上海）有限公司
企业类型 有限责任公司（外国法人独资）
法人代表 Angelika Ruf
经营状态 存续
成立时间 2019-02-28
注册资本 20万瑞士法郎
认证资质
营业执照信息
