Reg & Start Up Spec

1 week ago

Sydney, New South Wales, Australia Iqvia Full time

Regulatory and Start Up Specialist

We are currently looking for Regulatory and Start Up Specialists to join one of our FSP models. You will manage and execute the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements.

**Responsibilities include**:

- Perform Study Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
- Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites in Australia and New Zealand.
- Prepare / review ethics and regulatory documentation, reviewing for completeness and accuracy.
- Review, prepare and negotiate site contracts and budgets with sites.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Ensure all relevant documentation and approvals are in place to authorize Investigational Product release.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure overall project efficiency, quality and adherence to project timelines.

**Skills and experience required**:

- Bachelor's Degree in Life Sciences or equivalent work experience is required
- 2 - 3 years' experience Clinical Research or Site Start-Up within a CRO/Pharmaceutical Company, ideally in Australia/New Zealand is required
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills with ability to challenge, if applicable
- Effective communication, organizational, and interpersonal skills

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