About the Research Centre
In collaboration with CityU, University of Oxford, and Karolinska Institutet, the Hong Kong Centre for Cerebro-cardiovascular Health Engineering (COCHE) was established with the support of the ITC-InnoHK Programme to develop new ways to tackle cardiovascular disease (CVD), which is the world's leading cause of morbidity and mortality. To address the most pressing health challenges caused by CVD, COCHE focuses on developing innovative technologies such as flexible and wearable devices, biomedical and molecular imaging, nano-biosensing, micro-robotics, healthcare AI systems, and other ground-breaking methods to enable early prevention, diagnosis, and intervention of the disease. These technologies can reduce human costs while alleviating financial and social burdens on the healthcare system. For more information on COCHE, please visit: https://www.hkcoche.org/
Job Description
We are seeking a highly skilled professional with a medical background to coordinate and manage multi-center clinical trials, ensuring compliance with ICH-GCP and Hong Kong/Mainland regulations. This role requires regular travel between Hong Kong and Mainland China to oversee trial execution and stakeholder collaboration.
Responsibilities:
Trial Management: Oversee end-to-end clinical trial processes, including protocol design, site selection, ethics submissions, and data monitoring.
Stakeholder Coordination: Act as the primary liaison between cross-border sites, CROs, and regulatory bodies to ensure adherence to timelines, quality, and compliance.
On-Site Oversight: Conduct monitoring visits, risk assessments, and mitigation strategies to maintain trial integrity.
Regulatory Documentation: Prepare and review essential trial documents, including Investigator's Manual (IM) and progress reports aligned with regulatory standards.
Data Analysis & Reporting: Support data analysis and regulatory filings and perform other duties as assigned to advance COCHE’s mission.
General Qualification
Education: Master’s degree or higher in Medicine, Pharmacy, Public Health, or a related field (QS100 qualification preferred).
Experience:
Minimum 5+ years in Medical Affairs, preferably with medical device trials.
Strong knowledge of ICH-GCP, with global/multi-regional trial experience highly desirable.
Technical Skills:
Proficiency in EDC/CTMS systems and clinical trial software.
Fluency in English and Chinese (written and spoken).
Soft Skills:
Self-motivated, results-driven, and able to thrive in a fast-paced environment.
Willingness to travel (~25% of the time).
Preferred Hiring Qualifications:
Remuneration & Duration of Appointment
The remuneration package will be highly competitive, and commensurate with qualifications and experience. Fringe benefits for full-time appointments include leave and medical insurance, etc. Initial appointments will be made on a fixed-term contract. The possibility of re-appointment after the initial contract period will be based on performance evaluation and mutual agreements.
The application Materials that Should be Included
Application Closing Date:
The post is immediately available. Consideration of applications will be open until the position is filled.
Additional Information/links:
Application Procedures:
Please apply below or email your CV, cover letter including your current and expected salary and relevant documents supporting your qualifications to hr@hkcoche.org by specifying the job advertisement no. MAO. Only shortlisted candidates will be contacted.