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.
