📍 Location: Poland - Office based
🕓 Type: Full-time

Do you want to protect the safety & well-being of subjects and guarantee data quality? Do you get energy from daily communication with investigators, study coordinators and study teams? Do GCP ICH E6 R2 and ISO 14155 have no secrets anymore for you? Do you like to perform monitoring visits in hospitals and want to protect the safety & well-being of subjects and guarantee data quality? You might be the Lead Clinical Research Associate we are looking for at QbD Clinical!

🏢 What you’ll be doing

• Develop and execute monitoring plans through protocol analysis for remote risk management.

• Prepare for and conduct regular Site Compliance Meetings, reviewing KRI’s and any associated action items

• Ensure GCP compliance for monitoring clinical trials, including the implementation of future monitoring approaches.

• Evaluate the development of monitoring plans and employ efficient and accurate strategies for monitoring clinical trials.

• Collaborate with clinical KOLs and internal teams to manage clinical strategy.

• Utilize technology-enabled tools and risk evaluation approaches for remote monitoring.

• Provide training to monitoring team and support to site personnel to ensure high-quality data collection and regulatory compliance.

• Continually monitor data and analyze findings to decide whether to conduct a remote or targeted on-site monitoring visit.

• Review oversight of monitors and ensure adherence to service level agreements and legal and regulatory standards.

• Represent Site Management in Study Core team meetings

• Collaborate with Study team as needed for Audit response or Site Corrective Action Plan

💪 What you bring

• Master or Bachelor degree in biological or (para-) medical sciences or equivalent by experience

• Minimum of 3 years’ experience in clinical research in a CRO or hospital setting

• Fluent in Polish and English. Other language are a big asset.

• In-depth knowledge of RBM strategies

• Willing to travel internationally (<10%)

• 4 days per week office presence at client office in Warsaw

• Excellent interpersonal skills

• Strong Leadership skills: Ability to lead a team and work independently. Possesses good interpersonal skills, self-motivated, and retains a positive attitude. Ability to produce clinical trial deliverables within established timelines and budget. Strong analytical and problem-solving skills.

• Demonstrates ability to adapt to shifting priorities and competing demands

• Ability to maintain composure in difficult circumstances and sensitive to cultural differences.

💡 What’s in it for you?

• QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.

• Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.

• 1 year contract with possibility of extension

• As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.

• Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together

🫵 Who you are

Our culture is driven by values If this sounds like you, you’ll fit right in:

• You’re resilient and tackle challenges with a positive mindset

• You’re curious and always up for learning something new

• You have a no-nonsense approach honest, clear, respectful

• You’re innovative and bring ideas, not just opinions

• And above all, you’re serious about your work, but not too serious about yourself

✨ About us

We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.

We believe in JPEG:
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.

📩 Interested? Let’s talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.