开发创新疗法是科学领域中最具挑战性、最重要和最有个人价值的领域之一。在我们追求将创新科学转化为患者价值的过程中，成为安斯泰来的一员是一个令人兴奋的时刻！我们是一家拥有独特的合作和以患者为中心的文化的公司。现对以下职位进行公开招聘，欢迎符合条件的候选人投递简历。
Location：Beijing
Responsibilities:
1、Clinical Projects Planning and Tracking
• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
• Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
• Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data.
• Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team.
• Lead feasibility assessment and selection of countries and sites for study conduct.
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.
• Participate in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct.
2、Lead cross function team for the clinical studies
• Manage and lead cross-functional study teams, including vendors.
3、Timeline, Quality and Budget Management:
• Lead project team to manage the cross function team, vendors and CRO to meet the specific development timeline and ensure the quality within approved budget.
4、Early product development
• Join early product development.
5、Others
• Lead preparation and implementation for the inspections from authority
• Build up the good relationship with sites and KOLs
• Other clinical development related activities
• Provide oversight and direction to study team members for study deliverables; may provide direction to Clinical Study Managers, Associate Clinical Study Managers.
Qualifications：
1、Education
• Bachelor or master’s degree.
2、Skills
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
• Requires proven project management skills and study leadership ability.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Fluent in English. Moderate (25%) travel required.
3、Experience
• Minimum of 5 years working experience in the pharmaceutical industry or healthcare discipline including 3 years in a Clinical Research Associate (or equivalent/parallel) role and 2 years in project management.
职位申请：
简历接收邮箱: [email protected] (邮件主题：应聘岗位-姓名-地区）