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Biomarker Operation Lead
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**About the Job**
Join Excelya, where **Audacity, Care, and Energy** define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
**Main Responsibilities**
- Implement and execute the **biomarker strategy** across early and late-stage clinical development studies (Phases 1 to 3).
- Act as the **operational biomarker expert**, providing guidance to both internal teams and external stakeholders.
- Oversee all operational activities related to the **biomarker lifecycle**, from sample collection to analysis and reporting.
- Coordinate **assay development and validation** with external CROs to ensure readiness and timely sample testing.
- Collaborate with Translational Medicine and Procurement teams to **select and manage biomarker vendors**.
- Manage **timelines, budgets, risk, and quality plans** for all biomarker-related operational activities.
- Ensure biomarker sample management is compliant with **ICH-GCP** and relevant **regulatory standards**.
- Contribute to **clinical documentation** (protocols, ICFs, lab manuals) and respond to regulatory queries regarding biomarker plans.
- Support **site and team training** on biomarker sample handling and collection procedures.
- Collaborate with Translational Medicine and Data Management to **review biomarker data** and resolve queries or discrepancies.
**Requirements**:
**Experience**: Solid experience in drug development with over 3 years of involvement, including clinical or biological laboratory work focused on the handling and/or analysis of biological samples. Previous exposure to biomarker-related projects is considered an asset. Experience in outsourcing management is preferred
**Skills**: Proven project management abilities, strong critical thinking, and problem-solving skills. Sound understanding of general scientific principles applied to biomarker research, development, and implementation
**Education**: Master’s degree in a relevant scientific discipline
**Languages**: Fluent in English (spoken and written)
**Benefits**
**Why Join Us?**
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s **leading mid-size CRO**with the **best employee experience**. Our **one-stop provider service model**—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
**Excelling with care** means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
