Study Start-Up & Maintenance Senior Manager

Are you ready to transform clinical trial start-up timelines in one of the most complex regulatory environments? We are looking for a strategic and hands-on leader who can challenge the status quo, optimize processes, and drive faster, smarter study start-up execution in Mexico.

Your new department

You will be part of the Clinical Development Center (CDC), a high-impact team responsible for delivering clinical trials end-to-end.

The department combines strong operational execution with strategic influence, working closely with global teams and key external stakeholders such as regulatory authorities, ethics committees, and industry associations.

Within this structure, the Study Start-Up & Maintenance function plays a critical role as the backbone that enables clinical trials to start and run efficiently.

Your new role

As Study Start-Up & Maintenance Senior Manager, you will define the strategy and lead execution to accelerate clinical trial start-up and ensure efficient maintenance operations. You will:

• Define and execute study start-up and regulatory strategy for Mexico, optimizing timelines and ensuring compliance
• Lead end-to-end start-up & maintenance processes (submissions, contracts, budgets, imports/logistics, site/vendor payments)
• Drive continuous improvement initiatives, reducing internal cycle times in a complex regulatory environment
• Act as a key interface with external stakeholders (e.g., COFEPRIS, AMIF), influencing through a solution-oriented approach
• Lead and develop a multidisciplinary team (regulatory, contracts, logistics), ensuring performance and engagement
• Collaborate cross-functionally and globally, ensuring alignment with CDC and organizational priorities

Required skills & qualifications

• 5+ years of experience in study start-up within Pharma or CRO, with strong focus in Mexico
• Proven expertise in Mexican regulatory environment (COFEPRIS) and strategic stakeholder interactions
• End-to-end experience across regulatory submissions, contracts/budgets, importation/logistics, and site/vendor payments
• Demonstrated leadership as line manager, managing teams and multiple studies simultaneously
• Strong experience interacting with senior stakeholders (regulators, industry bodies, institutions)
• Fluent English with ability to operate in global environments

Nice to have:

• Exposure to multi-country operations (e.g., LATAM)
• Participation in industry forums or regulatory initiatives
• Experience driving cross-functional or organizational-level improvements

Key Capabilities

• Strong strategic thinking combined with execution excellence
• Ability to optimize processes and significantly reduce timelines
• Advanced stakeholder management and influencing skills
• High resilience, adaptability, and change management capability
• Strong leadership and team engagement, fostering a positive environment
• High ownership mindset with focus on solutions (“how can it be done”)

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

Being part of a global healthcare company means opportunities to learn and develop are all around us. You'll work alongside world-class professionals, gain exposure to cutting-edge clinical research, and build expertise that spans legal, compliance, and clinical operations. Our benefits are designed with your career and life stage in mind, supporting you as you grow with us.

More information

For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. To complete your application, click on "Apply now", attach your CV and follow the instructions.

Deadline

Please apply before June 25th, 2026. Applications are reviewed on an ongoing basis.

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.