Novartis Pharmaceuticals Corporation is hiring an SSO Study Start-up Team Lead to be accountable for the governance and oversight of a study start-up team in a standalone country. This remote role supports the country strategy to deliver operational excellence for the Global Drug Development portfolio in compliance with Novartis processes and regulatory requirements.
What You'll Do
- Support the country leadership team to identify innovative practices that optimize study start-up activities, increasing performance and business impact.
- Seek and evaluate external knowledge and best practices to enhance country trial operations.
- Support the country study start-up strategy in close collaboration with leadership and portfolio teams.
- Ensure timely start-up activities from country allocation until sites are ready-to-initiate.
- Ensure close collaboration with local IRBs/IECs and Health Authorities.
- Collaborate with portfolio and global teams to ensure study start-up timelines and country commitments are met.
- Accountable for the timelines, accuracy, and quality of TMF documents, including study start-up and ongoing maintenance for inspection readiness.
- Ensure adherence to financial standards, legislation, ICH/GCP, and all SOP requirements.
- Implement innovative and efficient processes in line with Novartis strategy.
- Manage hiring, training, development, and retention of Study Start-Up associates.
- Handle resource management and reporting for the Study Start-Up team.
- Ensure associates have the required skills to set up and execute studies with high quality.
- Manage and oversee productivity targets and serve as an escalation point for Study Start-Up functions.
What We're Looking For
- A degree in a scientific or health discipline.
- Minimum 5 years of experience in clinical operations and planning.
- Proven leadership capabilities and experience, with or without direct line management responsibilities.
- Understanding of all aspects of clinical drug development with emphasis on trial set-up, execution, and monitoring.
- Thorough understanding of the international drug development process, including strong knowledge of GCP/ICH standards and FDA/EMA and local Health Authority regulations.
- Strong capability in working in a global or country matrix environment.
- Proven successful leadership of teams, preferably with international team experience.
- Strong interpersonal, negotiation, and conflict resolution skills.
- Ability to communicate effectively in a local and global matrixed environment.
Team & Environment
This role supports the Study & Site Operations Country Leadership Team and manages a study start-up team in a standalone country.
Benefits & Compensation
- Comprehensive benefits package including health, life, and disability benefits.
- 401(k) with company contribution and match.
- Generous time off package including vacation, personal days, holidays, and other leaves.
- Performance-based cash incentive.
- Eligibility to be considered for annual equity awards.
- Compensation range: $138,600 - $257,400 per year.
Work Mode
This is a remote position open to candidates within the U.S. (remote anywhere, with some restrictions based on legal entity).
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
