Sr. Manager Study Operations

Found in: Talent CN S2 - 2 weeks ago

Beijing, China Astellas Pharma Inc. Full time

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

Accountability:

1、Evidence Generation Execution

• Lead feasibility assessment and selection of countries and sites for study conduct.

• Manage and lead cross-functional study teams, including vendors.

• Responsible for financial oversight of the program(s), requiring a strong financial acumen; proactively partners cross-functionally for updates to timelines and budgets.

• Development of RFPs, selection of CROs/vendors.

• Provide accurate and up-to-date study information within CTMS and other relevant tracking systems and provide regular updates of study progression to MA leadership 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.

• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and reviews 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.

• Provide oversight and direction to study team members for study deliverables.

2、Quality:

• Lead vendor oversight, as applicable to study type, in the management of day-to-day

operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH, GPP guidelines and other regulatory requirements, as applicable.

• 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.

Required:

• Educational Background: Bachelors in sciences or health-related field with at least 5 years global vendor oversight and clinical trial management experience in CRO, Pharmaceutical or Biotech company.

• Key Competencies:

▶Strong clinical study management skills (including project and financial management).

▶Excellent leadership, negotiation, and management skills.

▶CRO/vendor management experience, including experience in audits and inspections.

▶Clear demonstration of strong negotiation and influencing skills that lead to change.

▶In-depth knowledge of key interfacing organizations (finance, development, supply chain, regulatory etc.)

▶Business-fluent English.

▶Knowledge and/or experience working with groups across multiple countries and of varied cultural backgrounds.

▶Demonstrate strong organizational skills including ability to prioritize.

▶Ability to work virtually.

Preferred

• Experience with internal audits and regulatory inspections.

• Demonstrable understanding of late phase clinical development within a Medical Affairs setting.

• In-depth knowledge of global drug development, product lifecycle management, and clinical study design.

职位申请：

简历接收邮箱: (邮件主题：应聘岗位-姓名-地区）

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