Global Study Start-Up Lead

F. Hoffmann-La Roche AG; Hong Kong; On-site; HKD 900,000 - 1,300,000; Full time

Job summary

Roche in Hong Kong seeks a Senior Leader to drive country study start-up strategies for clinical trials, coordinating with local teams, global study groups and CROs to ensure timely site activation and regulatory compliance. You will manage submissions, ICF, budgeting, and cross-functional processes, translating global strategies into local execution while ensuring quality and patient safety.

Fluency in English and Cantonese, strong leadership, and deep knowledge of ICH-GCP and regional

Qualifications

• Degree in life sciences or equivalent; postgraduate degree desirable.
• Demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration.
• Strong understanding of ICH-GCP, EU CTR, and local regulatory environments.
• Experience managing vendor/CRO relationships.
• Proven leadership or line management experience for project leads.

Responsibilities

• Lead country study start-up strategy and execution with external stakeholders.
• Oversee start-up operations, site activation, and regulatory compliance.
• Ensure alignment with global strategies and timelines across functions.
• Manage amendments throughout the study lifecycle.
• Identify opportunities for process automation and standardisation.
• Collaborate with regional and global teams to harmonise systems and timelines.

Skills

Communication

Organizational skills

Analytical thinking

English fluency

Cantonese

Education

Life sciences degree

Postgraduate degree desirable

Tools

Veeva Vault

CTIS

RIM

Job description

Roche in Hong Kong seeks a Senior Leader to drive country study start-up strategies for clinical trials, coordinating with local teams, global study groups and CROs to ensure timely site activation and regulatory compliance. You will manage submissions, ICF, budgeting, and cross-functional processes, translating global strategies into local execution while ensuring quality and patient safety.

Fluency in English and Cantonese, strong leadership, and deep knowledge of ICH-GCP and regional