Be responsible for the on time, quality, within budget delivery of global and local medical affairs clinical study and program for key productsPrepare 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 ProtocolMonthly 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 TeamLead preparation and delivery of study documents ( Protocols / amendments, ICF, CRF, study related forms, etc.)Prepare and lead investigator and monitor meetingEnsure SAE reporting according to GCP and regulationPlan and lead activities associated with study level Quality Control planDevelop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriateProvide operational support to the ESR investigators to ensure the on time delivery of ESRUpdate study information into IMPACT,ESRand / or global & regional team to ensure up-to-date information capturedClinical study and program progress on trackActual vs. Plan on budget, timeline of clinical study and programTimely update in IMPACT, ESR / global & regional teamNo critical audit findings for post-marketing clinical programFeedback from line manager, direct reports and Brand Team membersOptimize existing local process / working instruction on clinical study and programProvide input to local process on clinical study and programShare best practice within teamFeedback from line manager and direct reports.Develop KOL through the clinical study and programWork 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 studyFeedback from internal / external customersAstraZeneca 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
09-5月-2024
Closing Date
29-9月-2024