We’re searching for a knowledgeable, team-oriented Senior CRA 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 a variety of therapeutic indications. You will maintain the highest quality standards in the industry, while performing and supervising study start-up, clinical monitoring and site management activities on the country/regional level.
You will become one of our first team members in Malaysia and contribute to the development of PSI Operations.
You will:
- 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.
The ideal candidate must possess the following qualifications:
- 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.
How are we different?
PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.
Growth Opportunities
PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.
