Pharmaceutical Research Expert

1 week ago


Kuala Lumpur, Kuala Lumpur, Malaysia Pharmaceutical Research Associates, Inc Full time
Responsibilities
  • Site Management: Oversee all aspects of study site management to ensure high-quality data and consistently low query levels.
  • Investigator Relations: Establish relationships with potential Investigators, prepare IEC/IRB submissions, and negotiate investigator budgets.
  • Clinical Trial Set Up: Contribute to Case Report Form design, clinical trial document development, and monitor guidelines.
  • Study Execution: Perform site initiation, routine monitoring visits, and close-out visits to ensure seamless trial execution.
Qualifications

To excel in this role, you should have:

  • A degree in Pharmacy or a related field.
  • 4+ years of prior monitoring experience with global trials.
  • Excellent knowledge of international guidelines ICH-GCP, GMP/GDP, and local regulations.
  • Good understanding of Clinical Study Management, including monitoring, study drug handling, and data management.


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