We are currently looking for Regulatory and Start Up Specialists to join IQVIA across the NZ region. 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 either at the global, regional, or country level.
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
Knowledge and ability to apply ICH GCP and applicable regulatory guidelines
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world.
The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.