Clinical Site Activation & Regulatory Lead

阿斯利康; Hong Kong; On-site; HKD 550,000 - 850,000; Full time

Benefits offered by this job

Mentorship and academic training

Group health insurance

Meal subsidies

Regular health checkups

Medical and children’s health ins.

Snack provisions

Five insurances and housing fund

Flexible benefits

Free lunch

Supplementary business insurance

Company pension

Annual bonus

Commuting allowance

Job summary

AstraZeneca in Hong Kong is seeking a qualified Clinical Trial Support professional to coordinate study startup activities, manage regulatory documents, and activate trial sites. You will work with local teams and DO, R&D China to ensure timely delivery of regulatory binders and master files, while maintaining ANGEL and IMPACT entries.

The role requires English fluency, knowledge of ICH-GCP and GMP/GDP, and the ability to travel nationwide.

Qualifications

• Fluent in English (spoken and written).
• ICH-GCP and GMP/GDP guidelines knowledge.
• Knowledge of local regulations related to clinical studies.
• Understanding of drug development process.
• Strong written and verbal communication; good negotiation skills.
• Experience in Clinical Study Management including monitoring and data management.
• Willingness to travel nationally.

Responsibilities

• Manage essential regulatory and trial documentation in line with ICH-GCP and AZ procedures.
• Assist coordination of clinical studies from site selection through activation.
• Participate in local Study Delivery Team meetings and cross-functional work with Clinical Trial Support.
• Activate study sites per procedures and track site progress and activation risks.
• Maintain data in IMPACT and TMF systems; ensure essential documents are filed.
• Prepare for audits and inspections with local teams and QA.
• Ensure compliance with AZ Code of Conduct and policies.
• Maintain study master file completion for startup documents and site activation.
• Create/import regulatory documents into ANGEL per GDL and AZ guidelines.
• Set up and maintain information in tracking tools and support usage by others.
• Communicate with key sites to influence trial delivery at hospital level.

Skills

English fluency

ICH-GCP knowledge

GMP/GDP knowledge

Regulatory knowledge

Strong communication

Drug development understanding

Study management experience

Travel willingness

Education

University degree in life science or related discipline

Tools

ANGEL (Global Document Library)

IMPACT/SharePoint

Job description

AstraZeneca in Hong Kong is seeking a qualified Clinical Trial Support professional to coordinate study startup activities, manage regulatory documents, and activate trial sites. You will work with local teams and DO, R&D China to ensure timely delivery of regulatory binders and master files, while maintaining ANGEL and IMPACT entries.

The role requires English fluency, knowledge of ICH-GCP and GMP/GDP, and the ability to travel nationwide.