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Scientific Operational Specialist

Plats Shanghai, Shanghai Shi, Kina Jobb-id R-123740 Datum inlagd 11/15/2021

Responsibilities:

  • Working closely with the clinical team and other supporting functions, deliver biomarker plan for clinical studies based on study strategy led by TM leaders.
  • Work with strategy functions to manage external alliance, support China TM contracts and Chinese translation of relevant documents for external activities including assay transfer, vendor evaluation and collaborations; support HGR applications for external translational research sponsored by AZ.
  • Work effectively with procurement to contract the biomarker operations to deliver fit-for purpose laboratory testing from sample receipt to delivery of results, compliant with clinical sample testing guidelines where necessary.
  • Ensure biomarker plan  commitment and CROs/laboratories to deliver timely testing; develop site requirements and contracts for sample logistics; Support biomarker data and sample reconciliation as needed.
  • Ensure HGR compliance by tracking study-related approvals, assure compliance of on-going and legacy studies, sample management.
  • Lead the creation and maintenance of study documents such as communication, quality management and issue escalation plans.
  • Review and approve sample instructions for clinical sites when necessary; Monitor biomarker sample quality and timeliness via agreed QC plan; Be accountable for the time, cost and quality of agreed deliverables.
  • Monitor and ensure compliance with all AstraZeneca Policies and Standards, HGR regulations and China biosafetey laws, and address instances of non-compliance. 

Education, Qualifications:

  • Bachelor's degree required, with at least 3 years of relevant experience in the biopharmaceutical industry
  • Demonstrable understandings of clinical studies process
  • Understandings for Human Genetic Resource regulations and previous experiences in application, amendment and submission processes.
  • Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice and Quality Systems Regulation)
  • Ability to identify risks and escalate appropriately
  • Good interpersonal skills and ability to act as an ambassador for TM/AZ internally and externally
  • Ability to interact successfully with multiple customers across functional boundaries
  • A confident team player with understanding of strategic directions and know when to escalate.
  • Excellent organizational skills, with the proven ability to deliver high quality work under pressure and against tight timelines

【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。】



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 authorisation and employment eligibility verification requirements.

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