Aisya Fathiya Che Rosli

As a GCP-certified TMF Specialist, I have honed my skills in ensuring compliance with regulatory standards and maintaining accurate documentation. With a strong background in clinical trial management, I possess profound knowledge of guidelines and systems for ethics committee and regulatory authority. My experience in process management and attention to detail has enabled me to excel in my roles.

Throughout my career, I have demonstrated the ability to collaborate with cross-functional teams to achieve study targets. I am well-versed in clinical trial phases, applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and ICH guidelines. My expertise in TMF content review, document indexing, and quality review has been instrumental in ensuring the integrity of trial data.

I am a strong communicator with excellent interpersonal skills, able to liaise effectively with project teams and TMF leads to ensure seamless execution of study-specific processes. I am committed to staying up-to-date with industry developments, having completed certifications in Good Clinical Practice (GCP) and Data Safety and Monitoring Board for Clinical Trials.