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Medical Research Associate Director

1 week ago

Kuala Lumpur, Kuala Lumpur, Malaysia PSI CRO AG Full time
Role Summary

We're seeking a seasoned Senior Clinical Research Associate to lead the clinical aspects of full-service global projects in Malaysia.

About the Job:

  • Supervise study activities, timelines, milestones, and schedules on the country level.
  • Conduct and report all types of onsite monitoring visits.
  • Be involved in study set-up, including site contract and budget negotiations.
  • Be responsible for site communication and management.
  • Ensure consistency of all study processes and identify country differences.
  • Oversee maintenance of study-specific and corporate tracking systems.
  • Contribute to the development and update of project planning documents, essential documents, and project instructions.
  • Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.
  • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
  • Development of local language materials including local language Informed Consents and translations.
  • Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

About You:

  • Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience. Registered pharmacists are strongly preferred.
  • Minimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertise.
  • Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials.
  • Proficiency in feasibility assessment and study set-up processes is highly desirable.
  • Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage.
  • Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment.
  • Superior communication, collaboration, and problem-solving skills are essential.
  • Willingness and ability to travel extensively within Malaysia is a prerequisite for this position.