Clinical Trials Site Lead & Start-Up Specialist

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

Job summary

Parexel in Hong Kong is seeking a Site Start-Up Lead to manage end-to-end startup activities for assigned clinical sites. You will coordinate with investigators and regulatory bodies, ensuring timely feasibility assessments, approvals, and study initiation.

Role requires strong problem solving, stakeholder management, and experience in regulatory submissions. Occasional travel and collaboration with global teams are expected.

Qualifications

• Knowledge of ICH-GCP guidelines and clinical trial basics.
• Experience with site management and regulatory submissions is valued.
• Strong written and spoken English; ability to communicate with international teams.

Responsibilities

• Act as Parexel’s direct contact with assigned sites during start-up, ensuring quality and delivery.
• Build relationships with investigators and site staff.
• Conduct country-specific feasibility and site qualification activities.
• Prepare, negotiate, and facilitate regulatory documents and amendments.
• Submit IRB/IEC and MoH/RA applications and manage follow-ups.
• Support site access to study systems and ensure training compliance.
• Monitor site activity through initiation to close-out and optimize recruitment strategies.
• Maintain CTMS data timely and accurately.

Skills

Problem solving

Independent work

Presentation skills

Client focus

Interpersonal communication

Time management

Travel willingness

Education

Biological sciences / Pharmacy degree or equivalent

Job description

Parexel in Hong Kong is seeking a Site Start-Up Lead to manage end-to-end startup activities for assigned clinical sites. You will coordinate with investigators and regulatory bodies, ensuring timely feasibility assessments, approvals, and study initiation.

Role requires strong problem solving, stakeholder management, and experience in regulatory submissions. Occasional travel and collaboration with global teams are expected.