摘要
Location: Singapore
Are you ready to lead a high-performing team that drives the early success of clinical trials? At Novartis, we are looking for a passionate and experienced Study Start-Up Team Lead to join our Development organization in Singapore. In this pivotal role, you will oversee the governance and execution of study start-up activities, ensuring operational excellence and regulatory compliance across our clinical portfolio. If you thrive in a matrixed, fast-paced environment and are eager to make a meaningful impact on patients' lives, we want to hear from you.
About the Role
Key Responsibilities:
- Lead and manage the end-to-end study start-up process from country allocation to site Green Light (ready-to-initiate).
- Support the development and execution of the country/OPC study start-up strategy in alignment with global and local priorities.
- Collaborate with internal stakeholders including Portfolio Heads, Global Study Teams, and Health Authorities to ensure timelines and deliverables are met.
- Ensure high-quality and inspection-ready Trial Master File (TMF) documentation throughout the study lifecycle.
- Drive innovation and continuous improvement in operational processes to enhance performance and productivity.
- Oversee hiring, training, development, and retention of Study Start-Up associates about 12 team members
- Serve as the escalation point for study start-up issues and ensure timely resolution.
- Ensure compliance with ICH/GCP, IRB/IEC, Health Authority regulations, and Novartis SOPs.
- Partner with SSU CRAs and global SSU managers to align on portfolio deliverables and essential document collection.
- Monitor and report on productivity targets and performance metrics.
Essential Requirements:
- Bachelor’s degree in a scientific or health discipline
- Minimum 5 years of experience in clinical operations and planning, with a strong focus on study start-up.
- Proven leadership experience, with or without direct line management responsibilities.
- In-depth understanding of clinical drug development, especially trial set-up and execution.
- Strong knowledge of international regulatory standards (ICH/GCP, FDA, EMA) and local Health Authority regulations.
- Experience working in a global or country matrix environment.
- Excellent interpersonal, negotiation, and conflict resolution skills.
- Strong communication skills in a cross-functional, multicultural environment.
- Ability to lead teams and drive results in a dynamic, high stakes setting
Commitment to Diversity and Inclusion / EEO paragraph:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams
representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
