The applicant is expected to manage clinical study in the areas of Chinese medicine, biomedical sciences or related disciplines.
Responsibilities:
- Responsible for planning and leading the delivery of all components of a clinical study operation to time, cost, and quality from study start-up through closeout activities and clinical study report;
- Responsible for the clinical operation activities including but not limited to clinical study subject recruitment, clinical monitoring, data verification, drug supply management and vendor management;
- Oversee study centres’ compliance with study protocols, Good Clinical Practice (GCP) and other research ethics and regulatory requirements, and write monitoring reports; Oversee onsite clinical data management activities to ensure data integrity and quality; Facilitate study audits and inspections when needed;
- Support the project leaders’ management in multi-functional clinical project teams by collaborating effectively with internal stakeholders including the leadership team, clinical team, regulatory affairs, preclinical team, etc.;
- Being the primary point of contact for the assigned project for clinical study centres and investigators; and
- Undertake any other duties assigned.
Requirements:
- A bachelor’s degree or above in Health, Biological/Life Sciences, Medical, Pharmacy, Nursing or related disciplines;
- At least 5 years of clinical monitoring, including at least 2 years recent clinical research experience in the capacity of project manager/equivalent (clinical study team lead, clinical study manager, etc.);
- Proven experience leading and managing all stages of clinical studies (feasibility, start-up, execution, close-out); Experience managing phase 2 or phase 3 randomised controlled trials in therapeutic research for Gastrointestinal diseases and neurological diseases is preferred;
- Deep knowledge of GCP guidelines in pharmaceutical product development is required;
- Should have a good command of written and spoken English and Chinese, as well as good interpersonal and organisational skills;
- Should be responsible, attentive to details and able to work independently; and
- Innovative, self-motivated with good planning and organisational skills are essential.
The initial appointment will be offered on a fixed-term contract of 2 year. Re-appointment thereafter will be subject to performance and availability of funding.
Salary will be commensurate with qualifications and experience.
Application Procedure:
Applicants are invited to submit their applications at the HKBU e-Recruitment System. Those who are not invited for interview 8 weeks after submission of application may consider their applications unsuccessful. Details of the University’s Personal Information Collection Statement can be found at https://hro.hkbu.edu.hk/en/worklife-at-hkbu/employee-favourable-environment.html#privacy-policy.
The University reserves the right not to make an appointment for the post advertised, and the appointment will be made according to the terms and conditions applicable at the time of offer.
Review of applications is ongoing until the positions are filled.
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