Senior Clinical Research Associate

Job Description Summary

Job Title: Senior Clinical Research Associate (CRA)

#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.

 

Job Description

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/

 

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences