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#LI-Hybrid
Primary Location: Prague, Czech Republic
Relocation Support: This role is based in Prague. Novartis is unable to offer relocation support: please only apply if accessible.
Drive clinical trials forward where it matters most - at the site level and with patients at the center. As a Senior CRA at Novartis, you will manage trusted site relationships and perform on-site and remote monitoring activities to support the initiation, conduct, and timely completion of Phase I – IV trials in compliance with International Council for Harmonization / Good Clinical Practices (ICH/GCP), local regulations, Standard Operating Procedures (SOPs), and monitoring procedures. Serving as a key point of contact for investigational sites, you will proactively manage site performance, recruitment, quality, risks, and issue resolution to ensure sustainable trial execution and high-quality data delivery. Assigned to complex trials and/or less experienced sites, you may also act as a Subject Matter Expert, support audit and inspection readiness activities, ensure timely implementation of corrective actions, and collaborate with local and global cross-functional teams to drive process improvements that help bring innovative therapies to patients faster.
About the Role
Key Responsibilities
- Lead assigned sites as the primary point of contact throughout study delivery
- Build strong relationships to ensure site performance, quality, and milestone achievement
- Manage Phase I to Phase IV trials per monitoring plans and company procedures
- Conduct site initiation visits and deliver ongoing training for site personnel
- Perform remote and on-site monitoring to ensure compliance and patient safety
- Maintain accurate documentation and update all clinical systems in a timely manner
- Identify risks, resolve issues, and escalate concerns as needed
- Collaborate with cross-functional teams to drive efficient study execution
- Support timely data query resolution and ensure data accuracy
- Act as a subject matter expert across study activities when required
Essential Requirements
- Minimum of three years of clinical site monitoring experience
- Minimum of Bachelor’s degree in science, healthcare, or a related field
- Strong understanding of clinical research and drug development processes
- Knowledge of ICH/GCP and European regulatory requirements
- Ability to manage multiple priorities and work independently
- Strong site management, communication, and problem-solving skills
- Fluency in written and spoken Czech/Slovak and English
- Ability to travel extensively, including both domestic and international
Desirable Requirements
- Experience in radioligand therapy, chimeric antigen receptor T-cell therapy, or oncology
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; Public Transportation Allowance.
Find out more about Novartis Business Services: https://www.novartis.cz/
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: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to di.cz@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
