Sr./Associate Director, CPM

Be responsible for the on time, quality, within budget delivery of global and local medical affairs clinical study and program for key products

Prepare and deliver study level feasibility, and develop recruitment strategies, and the delivery of the approved Clinical Study Protocol .The job holder will lead a team to develop and deliver study results and ensure study meet local, regional and globally agreed timelines.

Responsible for the delivery of clinical study to time, quality and budget in compliance with GCP/SOPs, local regulations and the Clinical Study Protocol

Monthly track and manage to agreed project timelines, budget and resource to 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 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

Clinical study and program progress on track

Actual vs. Plan on budget, timeline of clinical study and program

Timely update in IMPACT, ESR /global & regional team

No critical audit findings for post-marketing clinical program

Feedback from line manager, direct reports and Brand Team members

Optimize existing local process/working instruction on clinical study and program

Provide input to local process on clinical study and program

Share best practice within team

Feedback from line manager and direct reports.

Develop KOL through the clinical study and program

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

Investigator’s future engagement in AZ study

Feedback from internal/external customers

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 Posted09-5月-2024

Closing Date29-9月-2024

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.

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