Senior Clinical Research Associate Full Time NEW

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.

Requirements:

• 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.

Benefits:

• Growth opportunities through various development programs.
• On-the-job learning experiences.
• Chance to work with a privately-owned company with a significant independent edge.
• Opportunities for career development and skill enhancement.