Site Activation & Regulatory Lead (Clinical Trials)

GSS招聘; Hong Kong; Sur place; HKD 420 000 - 620 000; Plein temps

Avantages offerts par ce poste

Flexible Working Time 灵活的工作时间

Paid Annual Leave 带薪年假

Paid Medical Leave 带薪病假

Maternity Leave/Paternity Leave 产假/陪产假

Marriage Leave/Compassionate Leave 婚假/

Wellness & Engagement Activities 员工体检&

Outing & Team Building 形式多元的团队建设

Social Clubs 员工俱乐部

Commercial Medical Insurance 补充医疗保险

Online Training 线上培训

Internal Transfer 内部转岗

Résumé du poste

GSS招聘 is seeking a Site Optimization Officer/Associate Manager to coordinate clinical studies from site selection through activation in Hong Kong. You will ensure ICH-GCP compliance, manage EC applications, study agreements, and essential regulatory binders, while driving document delivery and mitigating start-up risks.

You will work with local and China SM&M teams, maintain the TMF via Veeva, support audits, and participate in cross-functional delivery meetings.

Qualifications

• University degree in life sciences or related field.
• Fluent knowledge of spoken and written English.
• Willingness to travel nationally as required.
• Excellent knowledge of ICH-GCP and regulatory guidelines.
• Good understanding of Clinical Study Management including monitoring and data management.

Responsabilités

• Maintain essential documentation in compliance with ICH-GCP and Procedural Documents.
• Coordinate clinical studies from site selection through activation and initiation.
• Obtain EC approvals from confirmed sites and finalize study agreements.
• Prepare and file regulatory binders and TMF records in Veeva.
• Drive regulatory document delivery and manage start-up delays and risks.
• Support audits and regulatory inspections with local QA and Study Delivery Team.

Connaissances

English proficiency

National travel

Formation

Bachelor degree in life sciences or related field

Outils

Veeva TMF

IMPACT

SharePoint

Description du poste

GSS招聘 is seeking a Site Optimization Officer/Associate Manager to coordinate clinical studies from site selection through activation in Hong Kong. You will ensure ICH-GCP compliance, manage EC applications, study agreements, and essential regulatory binders, while driving document delivery and mitigating start-up risks.

You will work with local and China SM&M teams, maintain the TMF via Veeva, support audits, and participate in cross-functional delivery meetings.