Site Activation Specialist

3 days ago

Sydney, New South Wales, Australia beBeeSiteActivation Full time $90,000 - $130,000

About this Role:

We are seeking a highly skilled specialist to manage and execute start-up and site activation activities, as well as amendment activities.

Key Responsibilities:

• Serve as Single Point of Contact (SPOC) for assigned studies, working closely with investigative sites and project team members.

• Perform start-up and site activation tasks according to applicable regulations and work instructions.

• Provide local expertise to project team members during initial and ongoing project timeline planning.

• Prepare and review ethics and regulatory documentation, ensuring accuracy and completeness.

• Review, track, and follow up the progress of documents, questionnaires, and regulatory approvals.

• Negotiate study contracts with sites.

• Maintain accurate records in internal systems and databases.

• Perform quality control of documents provided by sites.

• Ensure all relevant documentation and approvals are in place for Investigational Product release.

Requirements:

• Bachelor's Degree in Life Sciences or equivalent work experience.

• 2-3 years' experience in Clinical Research or Site Start-Up within a pharmaceutical company.

• In-depth knowledge of clinical systems, procedures, and corporate standards.

• Excellent negotiating, communication, and interpersonal skills.

• Ability to work on multiple projects, balancing competing priorities.

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