Site Initiation and Management Professional

7 days ago

Sydney, New South Wales, Australia beBeeSpecialist Full time $90,000 - $120,000

Regulatory and Start-up Specialist

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We are currently seeking a skilled Regulatory and Start-up Specialist to manage and execute the site identification process. You will be responsible for performing regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements.

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Key Responsibilities:

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- Perform study start-up and maintenance activities according to applicable regulations, SOPs, and work instructions.
- Serve as Single Point of Contact (SPOC) for assigned studies for investigative sites in Australia and New Zealand.
- Prepare and review ethics and regulatory documentation 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.
- Establish and agree on project planning and project timelines, ensuring overall project efficiency, quality, and adherence to project timelines.

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Requirements:

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- Bachelor's Degree in Life Sciences or equivalent work experience is required.
- 2-3 years' experience in 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 necessary.
- Effective communication, organizational, and interpersonal skills.

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