Remote Clinical Site Activation Specialist

Parexel; Australia; Remote; AUD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Clinical Trial Site Activation Specialist to drive site activation and regulatory submissions across Australia. You will coordinate IIP preparation, IRB submissions, and communications with ethics committees while ensuring timely project milestones.

The role requires 2+ years in clinical site management, strong GCP knowledge, and ability to work across multiple sites. Travel may be required in a global environment.

Qualifications

• Minimum 2 years relevant experience in clinical site management.
• Fluent in local language and in English.
• Experience in pharmaceutical industry or CRO.
• Knowledge of ICH-GCP and regulatory requirements.
• Strong documentation and communication skills.

Responsibilities

• Activate sites and manage essential documents for trial initiation.
• Coordinate submissions to IRB/ethics boards and country authorities.
• Maintain TMF quality and timely filing of study documents.
• Support site audits/inspections and responses.
• Communicate study status to the team and sites.
• Provide SME input on site activation processes across countries.

Skills

Attention to detail

Independent work

Multi-tasking

GCP knowledge

Team collaboration

Computer literacy

CTMS

eTMF

Data entry

Education

Bachelor degree in Life Sciences

Tools

CTMS (e.g., Florence)

Shared Investigator Platform

Microsoft Office

Electronic TMF (eTMF)

Job description

Parexel is seeking a Clinical Trial Site Activation Specialist to drive site activation and regulatory submissions across Australia. You will coordinate IIP preparation, IRB submissions, and communications with ethics committees while ensuring timely project milestones.

The role requires 2+ years in clinical site management, strong GCP knowledge, and ability to work across multiple sites. Travel may be required in a global environment.