Job Description Summary
Location: Buenos, Aires
#Hyrbid position
Bring clinical trials to life from the very start. As a Study Start‑Up Manager at Novartis, you will play a pivotal role in accelerating the activation of innovative clinical studies that improve and extend lives. You will lead country‑level start‑up strategy and execution, navigating regulatory pathways, partnering with global and local stakeholders, and ensuring sites are fully ready to initiate with speed, quality, and compliance. This role offers the opportunity to shape how studies launch, influence timelines that matter, and operate at the heart of drug development in a highly collaborative, global environment.
Job Description
Key Responsibilities
- Lead country study start-up strategy and plans, partnering with portfolio leads and global study team.
- Drive start-up timelines from country allocation through Green Light readiness, meeting committed milestones.
- Prepare and submit ethics committee packages; review informed consent forms and manage amendments and updates.
- Coordinate health authority submissions with regulatory partners; respond to deficiency letters promptly and accurately.
- Maintain high-quality Trial Master File documentation for inspection readiness; ensure accuracy, completeness, and traceability.
- Lead site selection and readiness, ensuring documentation supports initiation and subsequent drug release.
- Chair local start-up meetings, align vendors and stakeholders, and implement corrective actions to meet Novartis standards.
Essential Requirements
- Degree in a scientific or health discipline (advanced degree preferred with clinical trial or project management experience).
- Fluent written and spoken English; local language capability as needed for the country scope.
- Minimum five years of clinical operations experience, including project oversight and/or clinical trial monitoring.
- Strong understanding of clinical drug development, especially trial set-up, execution, and monitoring.
- Demonstrated ability to lead in a matrix environment and influence without direct reports.
- Knowledge of Good Clinical Practice and International Council for Harmonisation standards, plus health authority expectations and Novartis standards
Skills Desired
Budget Management, Clinical Trials, Negotiation, Process Improvements, Project Planning, Vendor Management, Waterfall Model