About the role
Job Description Summary
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
Attachments
Skills Desired
Budget, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Analysis, Decision Making Skills, Financial Analysis, Health Sciences, LifesciencesAplyr's read
Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
What's promising
- •Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
- •The company offers a wide range of global career opportunities across various fields.
- •Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.
What to watch
- •Regulatory challenges can impact the speed of drug approval and market entry.
- •High competition in the pharmaceutical industry requires constant innovation to maintain market position.
- •Complex organizational structure may slow decision-making processes.
Why Novartis
- •Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
- •The company emphasizes a diverse and inclusive workplace culture across its global operations.
- •Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.
Aplyr’s read is generated by AI from public sources. Was it useful?
About Novartis
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.
