Site Activation Specialist

1 week ago

St Leonards, Australia IQVIA Full time

We are currently looking for **Site Activation Specialists** to join IQVIA across the ANZ region. You will manage and execute start up and site activation activities, plus amendment activities, in accordance with regulations, SOPs, and project requirements at a country level.

**Responsibilities include**:

- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Prepare / review ethics and regulatory documentation, reviewing for completeness and accuracy.
- Review, track and follow up the progress, the approval and execution of documents, questionnaires, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Review, prepare and negotiate study budgets and contracts with sites.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Perform quality control of documents provided by sites.
- Ensure all relevant documentation and approvals are in place to authorise Investigational Product release.
- Perform maintenance activities, including site budget and contract amendments.
- Review and provide feedback to management on site performance metrics.

**Skills and experience required**:

- Bachelor’s Degree in Life Sciences or equivalent work experience
- 2 - 3 years’ experience Clinical Research or Site Start-Up within a CRO/Pharmaceutical Company, ideally in Australia/New Zealand
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills, with ability to challenge
- Effective communication, organisational, and interpersonal skills
- Ability to work on multiple projects balancing competing priorities
- Willingness to learn and embrace emerging technology

If this sounds like you, please hit the **APPLY NOW** button and the Talent Acquisition Team is looking forward to speaking with you

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