Clinical Operations Program Associate Manager

The Clinical Operations Program Associate Manager (COPAM) supports for the activities on a program and compound level, and is mainly accountable for providing oversight to cost and resource, optimizing the process of global clinical trial design and execution strategies across studies. Additionally, this role also accountable for maintaining dashboards and matrices to the China-led or China alone studies.

The role holder supports delivery of clinical programs in the GMD area of responsibility & potentially supporting the delivery of programs within the ECD area of responsibility. Take responsibility and act as change agents for building and developing the Clinical Operations Program organization, processes and technology related to delivery of clinical studies or other core activities in GMD.

Typical Accountabilities

• PMO, project management office

• Maintain China-led study dashboard and matrix

• Responsible for change control maintenance for China-led studies including but not limited to:

• Monthly track of program level resources and budget
• Monthly track of global DO resources, specifically China DO
• Variation review/endorse with GPD on monthly basis

• Responsible of PLANIT set up and maintenance including

• Collaborating with Global Project Manager (GPM) to set up a new study under PLANIT for development operations
• Monthly progress confirm for ongoing studies/program

• Build TA template in Merlin and feasibility study

• Develop a TA-specific template in Merlin for any new study to easily copy and use
• Build TA feasibility database based on global feasibility analysis from every study (including ClinOps hurdles, country start-up projections, KEE sites, country RR assumption, etc.)

• Responsible of global IB maintenance support by

• Providing program/study level progress and Reviewing updated progress content
• Obtain endorsement from GPD on proposed IB update

• Facilitate group meeting including but not limited to GPD team meeting and other LT review meetings
• Monitor GPD group resource and allocation

Education, Qualifications, Skills and Experience

Essential

• Bachelor degree or equivalent in medical or biological sciences or discipline
• At least 5 years relevant clinical research experience in the pharmaceutical industry, academe or CRO, with 2-year experience of global clinical studies; ideally at least 2 years in a GSAM role (for internal candidate only)
• Advance knowledge of clinical research processes and regulatory requirements
• Demonstrated abilities in key clinical study management/drug development process
• Effective communication and advanced interpersonal skills with internal and external co-workers and stakeholders, including external service providers
• Demonstrated ability to collaborate as well as work independently
• Advanced computer proficiency and relevant project management/digital health tools in day-to-day tasks
• Fluent verbal and written communication in English
• Ability to manage competing priorities

Desirable

• Advanced degree in a scientific discipline
• Demonstrated good project management skills in own assigned area/scope/process or with low-to-medium complexity to drive results
• Ability to execute team leadership
• Experience in all periods of a clinical study lifecycle, from setup, maintenance and close-out
• Ability to increase productivity and innovation within assigned area(s)
• Ability to recognize opportunities for new ways of working

【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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】

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.