Job Description Summary
LI-HybridPrimary Location: Buenos Aires, Argentina
Other Locations: Ciudad de Mexico, Mexico
Relocation Support: Yes
Join Novartis and lead the way in transforming clinical trial operations across Latin America. As the SSO Study Start-Up Cluster Head, you’ll play a pivotal role in accelerating drug development by driving strategic start-up initiatives and fostering operational excellence. You’ll collaborate with global and local teams, regulatory bodies, and ethics committees to ensure timely, high-quality trial execution. This is your chance to make a meaningful impact in a purpose-driven organization that’s reimagining medicine and improving lives.
Job Description
Key Responsibilities
- Define and optimize cluster study start-up strategy in alignment with global and local priorities
- Lead timely execution of start-up activities from country allocation to site initiation readiness
- Collaborate with IRBs, IECs, and Health Authorities to ensure regulatory compliance
- Oversee trial allocation, initiation, and conduct to meet country-specific commitments
- Ensure accuracy and inspection readiness of Trial Master File documentation
- Promote adherence to financial, ethical, and regulatory standards across all operations
- Implement innovative processes aligned with Novartis strategy to enhance efficiency
- Foster a culture of compliance and ethical integrity in clinical trial execution
- Manage hiring, training, and development of the Study Start-Up team
- Monitor team productivity and serve as escalation point for operational challenges
Essential Requirements
- University degree in a scientific or health-related discipline
- Minimum 8 years of experience in clinical operations and planning
- At least 4 years of experience in people management and team leadership
- Strong understanding of clinical trial setup, execution, and monitoring
- In-depth knowledge of international standards including GCP/ICH and regulatory frameworks
- Proven ability to lead teams in a global or matrixed environment
- Fluent in both written and spoken English and local country language
- Excellent interpersonal, negotiation, and conflict resolution skills
Desirable Requirements
- Experience working with international teams in a global pharmaceutical environment
- Familiarity with digital tools and platforms used in clinical trial management
Skills Desired
Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Resource Management (Organizational), Risk Management
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