Assoc Director Site Management & Monitoring
AstraZeneca
Taipei,Taiwan
2天前

Back to our career areas Taiwan The role is responsible for delivering the committed part of all clinical interventional studies under his / her supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.

Typical Accountabilities includes but not limited to the followings.

  • Leadership of dedicated group, building the team spirit, developing team style and behaviour.
  • Oversees successful delivery of Clin Ops targets to plan, with speed and quality.
  • Contributes to the quality improvement of the study processes and other procedures.
  • Assists CH / CD SMM or Local Study Managers / teams in forecasting study timelines, resources, recruitment, study materials and drugs.
  • Provides direction to LSM / teams on major study commitments including resolving any key issues identified.
  • Reviews of monitoring reports / follow up letters of all direct reports as per study monitoring plan and / or local QC plans.
  • Supports SMM region in initiatives / activities as agreed with CH / CD SMM.
  • Ensures collaboration with local Medical Affairs Department / MSLs and related to clinical studies.
  • Ensures that study activities at country level comply with local policies & code of ethics.
  • Performs necessary accompanied site visits for direct reports, supporting ongoing coaching and development.
  • Qualification :

  • Minimum Master's degree in biological science or healthcare-related field, or equivalent.
  • Minimum 5 years' experience in Clinical Operations (CRA / Sr. CRA / LSM) or other related fields
  • Excellent organisational, analytical, influencing, negotiation skills.
  • Excellent presentation and communication skills, verbal and written.
  • Excellent knowledge of spoken and written English.
  • Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
  • Good ability to learn and to adapt to work with IT systems.
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