Senior Scientist (Clinical Research)

Hong Kong Baptist University; Hong Kong; On-site; HKD 600,000 - 900,000; Full time

Job summary

Hong Kong Baptist University, School of Chinese Medicine, Centre for Chinese Herbal Medicine Drug Development, invites applications for a Senior Scientist (Clinical research). The role focuses on managing clinical studies in Chinese medicine and related sciences, leading from start-up to close-out with strict adherence to GCP and regulatory standards.

The candidate will coordinate recruitment, monitoring, data verification, drug supply, and vendor management, while ensuring compliance and

Qualifications

• Bachelor’s degree or above in Health, Biological/Life Sciences, Medical, Pharmacy, Nursing or related disciplines.
• At least 5 years of clinical monitoring experience, with at least 2 years in a project-manager/equivalent role.
• Proven experience leading all stages of clinical studies (feasibility, start-up, execution, close-out).
• Deep knowledge of GCP guidelines in pharmaceutical product development.
• Proficiency in English and Chinese; strong interpersonal and organizational skills.

Responsibilities

• Plan and lead the delivery of all components of a clinical study from start-up to closeout.
• Oversee clinical operation activities including recruitment, monitoring, data verification, drug supply management and vendor management.
• Ensure study centres’ compliance with protocols, GCP and regulatory requirements; write monitoring reports; facilitate audits and inspections as needed.
• Support multi-functional clinical project teams by collaborating with internal stakeholders.
• Serve as the primary contact for the assigned project for clinical study centres and investigators.
• Undertake any other duties assigned.

Skills

Clinical monitoring

Project management

GCP knowledge

Data management

Regulatory compliance

Stakeholder collaboration

Education

Health/Life Sciences degree

Job description

SCHOOL OF CHINESE MEDICINE

CENTRE FOR CHINESE HERBAL MEDICINE DRUG DEVELOPMENT

Senior Scientist (Clinical research) (26270169)

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.

Salarywill becommensurate with qualifications and experience.