Clinical Trials Specialist

7 days ago

Petaling Jaya, Selangor, Malaysia George Clinical Pty Full time

About Us

We are a global Contract Research Organization (CRO) dedicated to advancing clinical research through scientific expertise and operational excellence.

Our team consists of passionate professionals working together to deliver better research and outcomes for millions worldwide.

The Job

This role involves undertaking specific regulatory tasks required for the implementation of clinical trials by George Clinical.

The successful candidate will be responsible for contributing updates in local clinical trial related regulatory requirements to our central library of related information.

  • Your Responsibilities:
  • Develop regulatory and project-related documentation as required and ensure it is kept up-to-date.
  • Maintain current knowledge of applicable clinical trial related regulatory information for designated countries.
  • Ensure timely sharing of updates to clinical trial related regulatory processes for designated countries with our head office.
  • Support the development and maintenance of clinical trial related regulatory SOPs, WIs, and ADs for designated countries.
  • Support internal training on clinical trial related regulatory processes for designated countries.
  • Liaise with study teams, sponsors, and investigators as applicable to prepare clinical trial related documents for submission to regulatory authorities.
  • Act as a local regulatory representative for any submissions to or requests from the regulatory authority of designated countries.
  • Collate, track, and review regulatory documents and packages according to project and country-specific requirements and timelines.
  • Provide project-specific updates and metrics relating to local regulatory submission status as required by project teams.
  • Provide regulatory support for project-related activities such as country-level feasibilities, observational studies, background research activities for proposals.
  • Ensure project files are kept up-to-date.
  • Liaise with regulatory services vendors, if applicable.

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