Senior Clinical Trial Manager
3 days ago
We are looking for a skilled Clinical Research Associate to join our team in Malaysia.
The successful candidate will be responsible for managing the clinical aspects of full-service global projects.
Main Responsibilities:
- 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.
Your Background:
- 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.
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