Assistant Registrar (to be seconded to GBAICTI as its Vice President)

Applications are invited for appointment as Assistant Registrar (to be seconded to GBAICTI as its Vice President (Process Innovation & Optimization)) (Ref.: 530867) 

The Greater Bay Area International Clinical Trial Institute (GBAICTI) is a wholly-owned entity of the Government of the Hong Kong Special Administrative Region, positioning as a centralized clinical research facilitation platform with the mission and vision of creating and sustaining a thriving clinical research ecosystem and energizing the development of a healthy and wealthy society through biomedical innovation, research, translation and development in Hong Kong and the Greater Bay Area (GBA). The University of Hong Kong Li Ka Shing Faculty of Medicine (HKUMed) is appointed as the operator of GBAICTI. We are seeking a high calibre talent to join the operation team as Vice President (Process Innovation & Optimization).

Main Responsibilities:

• Report to the Chief Executive Officer (CEO) and supervise the Office of Research Process Innovation & Optimization (OPIO);
• Formulate and direct the implementation of strategies to establish a centralized coordination platform in collaboration with stakeholders (e.g. Hospital Authority, public and private hospitals/medical institutions, clinical trials centres and the biomedical industry) for facilitating clinical research in Hong Kong;
• Perform continuing evaluation of the clinical research ecosystem and formulate and implement process innovation and optimization strategies (including but not limited to digitalization strategies) for facilitating clinical research in Hong Kong and GBA, such as in the domains of research ethics review and oversight, research project contracting and financial management, participants recruitment and informed consent, clinical research operations and implementation, research data governance, source records management, quality management, and facilitation of monitoring, auditing and regulatory inspections;
• Promote quality enhancement and recognition of public and private hospitals/medical institutions in Hong Kong (e.g. by facilitating applications for accreditation as clinical trial institutions by the National Medical Products Administration (NMPA));
• Support the CEO in exercising corporate governance and compliance;
• Perform other duties as assigned.

Requirements:

• Holder of a bachelor’s degree (preferably with a higher degree) in medicine, pharmacy, biotechnology, life sciences or related subjects;
• A minimum of 10 aggregate years of professional and supervisory experience in the clinical research profession, acquired in the last 20 years;
• Good knowledge and experience in clinical research operations and processes, regulatory requirements and industrial standards;
• Solid track records in leading process optimization in biomedical enterprises, contract research organizations or clinical research institutions;
• Proficiency in common office applications (e.g. MS Office including Word, Excel and PowerPoint); Hands-on experience in project management and database applications (e.g. MS Project, Access and Visio) is an added advantage;
• Commitment to quality, integrity, confidentiality and compliance;
• Excellent leadership, organizational, project management and problem-solving skills;
• Strong interpersonal, communication and stakeholders management skills;
• Detail-minded, able to handle multiple concurrent tasks and self-motivated;
• A good command of spoken and written English and Chinese; Proficiency in Putonghua is an added advantage.