Study Start-Up & Maintenance Senior Manager

Category:Data & AI

Location:Mexico City, Mexico City, MX

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.

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- 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 integral 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 regulato

📌 Study Start-up (Ciudad de México)
🏢 Novo Nordisk
📍 Ciudad de México