Senior Global Trial Manager

5 days ago


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

About Our Company

PSI CRO AG is a privately-owned company founded by our current leadership team over 25 years ago. This organic growth has given us significant advantages and freedoms, allowing us to invest in our people and continue to grow as a company.

We believe that investing in our employees is crucial to our success. From entry-level team members to senior leaders, we offer a variety of opportunities for growth and development throughout your career.

Your Role

We're seeking an experienced Senior Clinical Research Associate to manage the clinical aspects of full-service global projects in Malaysia. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in various therapeutic indications.

You will be responsible for supervising study activities, timelines, milestones, and schedules on the country level, conducting and reporting onsite monitoring visits, and being involved in study set-up, including site contract and budget negotiations.

Key Responsibilities

Manage the clinical aspects of full-service global projects in Malaysia.Work on the frontline of communication with project stakeholders.Supervise study activities, timelines, milestones, and schedules on the country level.Conduct and report onsite monitoring visits.Be involved in study set-up, including site contract and budget negotiations.

Requirements

  • Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience.
  • 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.


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