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AstraZeneca

Global pharmaceutical company developing prescription medicines

Associate Clinical Research Manager

Clinical Research OperationsPosted on Nov 13
Full-timeShanghai, ChinaNo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree in biological science or a healthcare-related field, or equivalent, is required.
  • At least five years of experience in Clinical Operations (CRA/CSM) is required.
  • Solid knowledge of the drug development process, clinical study process, AZ procedural documents, international ICH/GCP guidelines, and relevant local regulations is required.
  • Excellent knowledge of site management and monitoring is required.
  • Fluency in spoken and written English is required.
  • Ability to learn and adapt to working with IT systems is required.

Responsibilities

  • Lead, guide, evaluate, and develop the team to ensure quality execution and delivery of site monitoring at assigned sites; build team spirit and contribute to an efficient SMM organization in close collaboration with the SMM Director.
  • Ensure adequate allocation of site monitoring resources for assigned studies and manage resource conflicts.
  • Build and retain an efficient CRA team by providing leadership and monitoring to CRAs.
  • Develop CRAs' professional capabilities and oversee their career development according to business needs and individual aspirations; provide career-development guidance, co-design individual development plans, and implement those plans.
  • Contribute to improving study processes and other procedures; oversee systems maintained by CRAs for quality; review CRA monitoring reports and follow-up letters according to study monitoring and local clinical quality management plans; and conduct necessary accompanied site visits for CRAs.
  • Assist the SMM Director or Local Study Manager/teams with forecasting study timelines, resources, recruitment, study materials, and drugs; guide Local Study Manager/teams on major study commitments, including resolution of identified key issues.
  • Contribute to development of the clinical investigator network and strategic cooperation with sites to support clinical trial execution.
  • Ensure CRAs comply with company policy and code of conduct.

Desired Qualifications

  • People coaching or mentoring experience is preferred.
  • Good understanding of the study drug handling process and data management process is preferred.
  • Ability to work with remote collaborators is preferred.
  • Ability to manage change positively for oneself and the team is preferred.
  • Ability to prioritize and handle multiple tasks is preferred.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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