Study Start-up Specialist (1.5years contract)

Drive the launch of life-changing clinical trials and see your work accelerate the path from development to patient care.

Your new role

As a Study Start-Up Specialist, you'll be at the critical intersection of regulatory compliance and trial execution, ensuring clinical studies launch smoothly and sites are activated efficiently. Your expertise will directly impact how quickly innovative therapies reach patients in need. This position is a contract-based position for the materinty leave coverage and the contract period is 1 year and 6 months.

Day-to-day your tasks will include:

• Leading and coordinating all study start-up activities for assigned trials, from submission strategy through to site activation and regulatory compliance
• Preparing, reviewing and submitting Health Authority and IRB dossiers in alignment with ICH GCP regulations, local requirements, and Novo Nordisk processes
• Customizing, translating and preparing key documents including Informed Consent Forms, patient materials, labels, and Clinical Trial Application documents at country and site levels
• Managing site activation activities including 'Green Light' readiness, coordination of supplies and equipment delivery, and preparation of drug release documentation
• Building and maintaining strong relationships with clinical sites, IRBs and Health Authorities while providing local regulatory insights to global stakeholders
• Performing Quality Control and uploading documents to eTMF, ensuring start-up milestones and timelines are consistently met
• Identifying potential risks proactively and taking action to prevent or mitigate issues that could impact trial progress

Your new department

You will be part of the Clinical Development Centre Team, responsible for executing clinical studies that bring innovative therapies from trial phase to patients. Within Clinical, we focus on ensuring that every study is conducted with the highest standards of quality, ethics, and regulatory compliance. Your role will be instrumental in ensuring timely site activation and seamless trial initiation across multiple countries and therapeutic areas.

Your skills & qualifications

We're looking for a Study Start-Up Specialist who thrives in a fast-paced environment where precision and collaboration are essential. You'll bring with you:

• 3+ years of experience in clinical trials, regulatory affairs, or submission management within the pharmaceutical or CRO industry
• Extensive experience with IRB submissions and a thorough understanding of start-up guidelines, dossier requirements, and global clinical trial application processes
• Strong project management capabilities including tracking, planning and prioritization of multiple workstreams simultaneously
• Proficiency in digital tools, clinical trial management systems (CTMS), submission management systems and publishing software
• Excellent written and verbal communication skills with the ability to manage relationships effectively across internal teams and external stakeholders at all organizational levels
• Strong critical thinking and analytical skills with high attention to detail to evaluate risks and identify opportunities
• Bachelor's degree in Life Sciences, Pharmacy, or a related field (preferred)

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.

Deadline

Until the completion of recruitment. There is a possibility that this job posting might be closed in the early stage depending on the volume of applications. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible. 

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.

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