Senior Research Operations Manager

1 day ago


Kuala Lumpur, Kuala Lumpur, Malaysia Psi CRO Ag Full time

We are a global Contract Research Organization (CRO) dedicated to providing high-quality clinical research services. Our team of experts is passionate about bringing new medicines to market and improving patient outcomes.

Job Description

We are seeking a skilled Senior Clinical Research Associate to manage the clinical aspects of full-service global projects in Malaysia. As a Senior CRA at PSI CRO Ag, you will work closely with project stakeholders to ensure the successful conduct of clinical trials in various therapeutic indications.

Your key responsibilities will include:

  1. Supervising study activities, timelines, milestones, and schedules on the country level.
  2. Conducting and reporting all types of onsite monitoring visits.
  3. Being involved in study set-up, including site contract and budget negotiations.
  4. Being responsible for site communication and management.
  5. Ensuring consistency of all study processes and identifying country differences.
  6. Overseeing maintenance of study-specific and corporate tracking systems.
  7. Contributing to the development and update of project planning documents, essential documents, and project instructions.
  8. Being a point of contact for in-house support services, contractors, global cross-functional teams, and vendors.
  9. Executing and overseeing clinical trial country submissions and approvals for assigned protocols.
  10. Developing local language materials, including informed consents and translations.
Qualifications

To be successful in this role, you must possess:

  • A Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience.
  • Minimum 4-5 years of independent on-site monitoring experience or equivalent expertise.
  • Extensive experience 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.


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