Site Optimization Officer

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

Job Descriptions

• Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents.
• Assist in coordination of clinical studies from site selection through site activation.
• Actively participate in local Study Delivery Team meetings and work cross functionally with Clinical Trial Support Team in DO, R&D China.
• Activate study sites in compliance with AZ Procedural Documents.
• Share information (metrics) on study site progress towards activation within local Study Delivery Team and DO, R&D China leadership as required.
• Drive delivery of regulatory documents at the sites. Proactively identify delays in start-up activities and the risks to the activation plan.
• Update IMPACT and other systems with data from centres as per required per Site Optimization Team (SOT) process.
• Ensure regulatory binders are provided for study site start up and/or delivered as per SOT process and agreement with Local Study Delivery Team.
• Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
• Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva).
• Ensure that all start up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
• Contribute to the production of study start up documents, ensuring template and version compliance.
• Create and/or import clinical-regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL.
• Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems.
• Regular communication with key/mega site and influences the trial delivery in hospital level.

Job Qualifications

• University degree in related discipline, preferably in life science, or equivalent qualification.
• Fluent knowledge of spoken and written English.
• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Good medical knowledge in relevant AZ Therapeutic Areas.
• Basic understanding of the drug development process.
• Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Ability to travel nationally as required.

Job Type

Recruitment Type：Experienced

Work Type：Full-Time

Benefits

• 导师带教，学术知识培训
• 商业保险
• 丰富补贴
• 定期体检
• 医疗保险及子女医疗保险
• 零食无限
• 五险一金
• 弹性福利
• 免费午餐
• 补充商业保险
• 企业年金
• 奖金
• 五险一金商业保险等福利
• 津贴
• 培训
• 保险
• 通讯补贴