Job Description Summary
We are looking to hire a multi-layered Study Start-Up (SSU) person who will balance leading a team of up to 7 people, with being accountable for the governance and oversight of study start up for the Czech Republic. At the same time, you will retain oversight through collaboration with other Team Leads for SSU in Switzerland, Slovakia and Austria and with external managers working for 3rd party suppliers to Novartis. You’ll also help support new initiatives, and the overall study start up country strategy and prioritization, to deliver operational excellence of the Global Drug Development (GDD) portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.
Job Description
Study Start-Up Strategy
Support Study & Site Operations Country Leadership Team to identify innovative practices to optimize country operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact
Drive expertise in EU CTR and ensure close collaboration with local IRBs/IECs and Health Authorities, as applicable
Allocation, initiation and conduct of trials
Collaborate with Head Portfolio, SSO Portfolio Team Leads and global study team (Clinical Operations Program Head, Trial Lead) to ensure SSU timelines and deliverables are met according to country commitments
People and resource management
Ensure associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectives
Archive
Ensure adherence to global procedures and standards as well as availability of and adherence to local processes and standards for filing TMF documents.
Essential Requirements
A degree in scientific or health discipline required
Fluent in both written and spoken Czech and English
Minimum 5 years’ 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 particular emphasis on trial set-up, execution, and monitoring
Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/national Health Authorities regulations and Novartis standards
Desirable Requirements
Proven successful leadership of teams (with or without direct reports), preferably with experience in working with international teams
Strong interpersonal, negotiation and conflict resolution skills; strong capability working and communicating effectively in a local/global matrixed environment
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
Benefits and rewards:
Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 5-week holiday per year; (1 week above the Labour Law requirement) ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Benefit Plus Cafeteria in the amount of 17,500 CZK per year; Meal vouchers in amount of 105 CZK for each working day (full tax covered by company); MultiSport Card. Find out more about Novartis Business Services:https://www.novartis.cz/
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility & Accommodation: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Skills Desired
Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall ModelSimilar Jobs
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
