JOB SUMMARY

The role and responsibility for the Project Manager is to maximize the value of clinical studies, include but not limit to well manage study timeline, quality and cost, study status delivery in a timely manner. Ensure that study implement in compliance with GxP, AZ SOPs and processes.

DUTIES & RESPONSIBILITES / 主 要 职 责

To be responsible for well managing study timeline, quality and cost

• Take a key leadership role in the management of  study timeline, quality and cost and must be in compliance with GxP and other applicable policies
• Monthly track and manage the agreed project timelines, budget and resource, highlight significant variance and take appropriate actions to get project on track
• Review and approve project relevant document
• Timely update projects information to the Brand Team
• Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, study related forms, etc.)
• Prepare and lead investigator and monitor meeting  
• Ensure AEs/SAE reporting according to GCP and regulation
• Plan and lead activities associated with study level  Quality Control plan
• Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate
• Provide operational support to the ESR investigators to ensure the on time delivery of ESR
• Update study information into IMPACT,ESR  and/or global & regional team to ensure up-to-date information captured

Optimize existing local process/working instruction on clinical studies

• Provide input to local process on clinical studies
• Share best practice within team

Develop KEE through the clinical studies.

• Work with Brand Team on KEE/potential investigators development activities including appropriate investigators and   sites selection, operational experience improvement through projects delivery in big city big hospital.

• Qualified to apply for China Merchants Bank Credit Card (Business expenses should be reimbursed through company credit card)

具备入职后能办理招商银行信用卡的资格（通过报销的业务消费必须使用公司商务信用卡）

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.