Povzetek
#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.
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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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
