Careers

As a Clinical Research Project Leader at United BioPharma you will be working on our clinical trials for the pipelines in development. You will be part of the UBP team developing site monitoring planning and its implementation according to ICH guidelines and CFDA including pre-study, site initiation, routine monitoring and close-out visits. The role will allow you to work on a close knit (and concise) team and mentored by your line manager and our board advisor for clinical/ regulatory strategies.

Competencies:

1. Contribute to clinical study start-up, execution, close-out and reporting
2. Understands how to interface with investigators, strategic partners, site management, monitoring and internal team members during the collection process
3. Understands how to initiate and lead the set up of the electronic Trial Master Fiel (eTMF) including tracking documents. Maintain and close the eTMF ensuring International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) compliance
4. Contribute to electronic applications/ submissions by handling clinical regulatory documents according to the requested technical standards (i.e.: submission ready standards (SRS), supporting effective publishing and delivery to regulatory authorities) Set up, populate and accurately maintain information at UBP tracking/ communication tools and support others in the usage of project management toolsResponsibilities
5. Acts as liaison between our research and development team in Taiwan, our research centre team in Shanghai, board advisor and regulatory authorities (including monitored sites)
6. Monitors the conduct of clinical trials and compliance with established timelines and quality standard
7. Ensures harmonization of in-house/regulatory monitoring and ethic practices

Requirements:

1. College nursing diploma or bachelor of health sciences, nursing, biomedical sciences, pharmacy, pharmacology or related discipline
2. Meticulous and detail oriented
3. Good communication skills
4. Bilingual (Chinese and English)
5. Verifies compliance and quality of collected data
6. Proficiency in the use of Microsoft Office suite