Trial Operations Lead

3 days ago


Kuala Lumpur, Kuala Lumpur, Malaysia Parexel Full time

This role requires a high degree of autonomy, with ability to work independently and make decisions in a fast-paced environment.

Job Description

As a Clinical Research Associate, you will be responsible for managing clinical trials from start-up to close out.

  • You will work closely with investigators and site staff to ensure that studies are implemented according to protocol.
  • You will assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites.
  • You will identify and evaluate potential data quality and integrity issues and determine appropriate follow-up actions.

Main Responsibilities:

  • Study Start-up and Maintenance:
  • Conduct remote Qualification Visits (QVs), generate visit/contact reports, and develop strategy to configure, distribute, collect, review, and approve country/site specific documents or essential regulatory documents.
  • Site Management:
  • Build relationships with investigators and site staff, facilitate and support site access to relevant study systems, and ensure compliance with project specific training requirements.

Requirements:

  • Able to work independently, seeking/taking guidance when necessary, with sound presentation skills and client-focused approach to work.
  • Able to manage multiple tasks and achieve project timelines, with strong computer skills including knowledge of CTMS, EDMS, and MS-Office products.


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