A

AstraZeneca

Global pharmaceutical company developing prescription medicines

Associate Clinical Research Manager

Clinical Research OperationsPosted on Nov 13
Full-timeGuangzhou, Guangdong Province, 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.
  • The candidate must have the ability to learn and adapt to working with IT systems.

Responsibilities

  • Lead, guide, evaluate and develop the team to ensure quality execution and delivery of site monitoring at the designated sites, build team spirit, and contribute to an efficient SMM organization by working closely 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 be accountable for their career development according to business needs and individual aspirations, including providing career-development suggestions, co-designing individual development plans, and implementing those plans.
  • Contribute to improving study processes and other procedures; oversee relevant systems maintained by CRAs; review CRA monitoring reports and follow-up letters in accordance with study monitoring and local clinical quality management plans; and perform necessary accompanied site visits for CRAs.
  • Assist the SMM Director or Local Study Manager/teams in forecasting study timelines, resources, recruitment, study materials and drugs, and guide Local Study Manager/teams on major study commitments, including resolving identified key issues.
  • Contribute to developing 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 preferable.
  • A good understanding of the Study Drug Handling Process and the Data Management Process is desirable.
  • The ability to work in an environment with remote collaborators is desirable.
  • The ability to manage change with a positive approach for oneself and the team is desirable.
  • The ability to prioritize and handle multiple tasks is desirable.
  • Learning agility is desirable.

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

Recently Posted Jobs

Explore more opportunities at AstraZeneca

See more jobs