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 Bachelors 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 17500 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: Desired

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