Clinical Trials Start Up & Regulatory Manager

• Be at the forefront of medical research and make a difference in patient care.
• Hybrid role, located in Macquarie Park.
• Flexible 35 hours work week and 9-day fortnight opportunity*

Join this prestigious institution at the forefront of medical research, with access to advanced facilities and collaborative opportunities with industry partners and research groups.This is a new opportunity for an experienced Clinical Trials Start-Up & Regulatory professional to join this growing Clinical Trial Unit. As the Clinical Trials Start-Up & Regulatory Manager, you will lead a group of Start-up and Regulatory Associates, managing through coaching, performance management and providing strategic advice and support for sponsored and investigator-initiated Phase I - IV Clinical Trials.You will join a dynamic, innovative team contributing to groundbreaking research, make a difference in patient care and have access to state-of-the-art facilities and support services, all located on campus.Guided by your expertise in Study Start Up and Regulatory Oversight, you will be pivotal in the strategic advice on research ethics, clinical trial regulations, and compliance with GCP and legislative requirements whilst Overseeing trial budgets and contract executions to mitigate risks to ensure organizational compliance.Reporting to the Head of Clinical Trials Unit, you will be contributing to strategic planning and and decision-making support for start-up and regulatory matters, ensuring future trials' success. You will have the opportunity to streamline regulatory, budget development, and contract execution processes to enhance efficiency and consistency and build relationships with key stakeholders to drive strategic Clinical Trials portfolios.Ideally, you will have the following:

• Substantial experience in Clinical Trials and Australian Clinical Trial regulations, working experience in study start-up and regulatory submission activities.
• Deep understanding of regulatory frameworks for Clinical Trials, ethics, and integrity issues, with a successful track record in managing these in a clinical trial setting.
• Experience in contract negotiations and team development, fostering a positive culture to deliver high-quality services.
• Excellent consultation and collaboration skills with diverse stakeholders.
• Proactive and supportive people management with a track record of inspiring and developing teams.

This is a hybrid position, located in Macquarie Park. The salary package includes 17 % superannuation, a flexible working arrangement of 35 hours work week/ 9 days fortnight and discounted parking on site.Please contact Christina Ntoka on 02 9431 2548 for a confidential discussion, we're always interested to hear from talented and engaging people like you. Get in touch and tell us about yourself.Interested in this job?Save JobShare this JobCreate AlertSimilar JobsConsultant Name: Consultant Email: Social AccountsSCHEMA MARKUP ( This text will only show on the editor. )Welcome to On Q Recruitment, a specialist Sydney based Life Sciences and Government recruitment agency.