Study Start-Up Manager

Study Start-Up Manager

Be the strategic force behind clinical trial success. Shape how we bring life-changing therapies to patients across Australia and New Zealand, turning regulatory complexity into streamlined pathways that accelerate access to treatment.

Your new role

As Study Start-Up Manager, you'll be the architect of our clinical trial launch strategy across Oceania. You'll transform complex regulatory landscapes into clear pathways, ensuring trials move from concept to activation with precision and speed. This isn't administrative coordination – it's strategic orchestration that directly impacts how quickly patients can access breakthrough treatments.

Your responsibilities will include:

- Developing and executing study start-up strategies for clinical trials, managing the entire journey from site selection through to activation

- Formulating smart submission strategies that reduce approval timelines and streamline regulatory requirements across multiple sites

- Preparing and localizing ethics and research governance submission packages, adapting global protocols to meet Australian and New Zealand regulatory standards

- Managing all interactions with Human Research Ethics Committees (HRECs), Research Governance Offices (RGOs), TGA, and Medsafe to secure timely approvals

- Building and owning standardized business processes for study start-up, identifying operational gaps and leading process improvement initiatives that enhance efficiency across the Clinical Development Centre

- Leading strategic planning of start-up activities in alignment with Trial Managers, ensuring synchronized execution across multiple sites to optimize timelines and resource allocation

- Acting as a subject matter expert and mentor, guiding the CDC team on best practices and navigating the evolving regulatory environment

Your new department

The Clinical Development Centre (CDC) Oceania, is a dynamic team committed to delivering excellence in clinical operations. As part of Clinical Operation Excellence, you'll work alongside Therapeutic Area Heads, Trial Managers, Clinical Research Associates, and Feasibility Managers to ensure our clinical portfolio progresses smoothly through regulatory approval processes. Your role will be pivotal in achieving our ambitious goal of 80% site activation at first patient first visit, directly accelerating patient access to innovative therapies.

Your skills & qualifications

We're seeking someone who thrives in complexity and sees regulatory challenges as puzzles to solve strategically. You'll bring:

- A minimum of 5 years' experience working in clinical research, preferably in study start-up functions or project management

- Bachelor's degree in Life Science, Communication, Biomedical Science, Business, or equivalent qualification

- Deep familiarity with Australian and New Zealand ethical and regulatory frameworks, including HREC, RGO, TGA, and Medsafe processes, coupled with current knowledge of ICH-GCP guidelines and regulations

- Proven project management capabilities with the ability to balance multiple priorities, manage competing timelines, and coordinate effectively across cross-functional teams and external stakeholders

- Strong negotiation skills and attention to detail, with experience preparing submission packages, managing approvals, and navigating complex institutional requirements

- Process improvement mindset – you naturally identify gaps, propose innovative solutions, and lead change management initiatives that create lasting operational excellence

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Applications are reviewed on an ongoing basis; we encourage you to apply now.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.