Jan 30, 2023

Job Description

Clinical Research Associate (CRA), Novartis, Poland

766 million patients were reached with Novartis medicines. We aspire to get Novartis medicines in the hands and homes of patients by delivering a Triple Win: A Win for Patients; A Win for Healthcare Systems, and A Win for Novartis.

As Clinical Research Associate you will perform monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within Poland.

Your key responsibilities:

• Managing assigned study sites and networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures;
• Being the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries;
• Performing remote and on-site monitoring activities to ensure compliance with protocol, ICH-GCP, global and local regulations, global and local processes to secure data integrity and patient safety;
• Conducting continuous monitoring activities (on-site and remote) to ensure that study milestones for sites responsible are met as planned; (i.e., study start-up, recruitment, database analyses, closeout, etc.)
• Conducting site visits including but not limited to selection visits, initiation visits, monitoring visits, close-out visits per SOPs and applicable regulations and documenting monitoring activities appropriately following Novartis standards;
• Identifying issues at sites; resolving issues and escalating as appropriate; supporting the implementation of innovative processes and technologies;
• Managing and maintaining information and documentation by updating all electronic systems (global and local) relevant to perform job functions;
• Participating from audit organization and inspection readiness activities for monitoring and site related activities as required and ensuring implementation of corrective actions within specified timelines.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

From the candidate we require:

• Fluent in both written and spoken Polish & English;
• Scientific education (e.g. medical, pharmaceutical, biology, biotechnology etc.).
• Previous monitoring experience (minimum 2 years) is essential gained in pharma/CRO.
• Desirable, Previous experience in oncology trials or ready to monitor oncology trials.
• Ability to travel domestically (a minimum of 50% overnight travel may be required).
• Ability to anticipate potential issues and take appropriate actions with or without supervision.
• We will value: good communication skills, ability to influence others and strategic thinking

Why consider Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
Research & Development
Full Time
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Clinical Research Associate (CRA)

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