Are you ready to drive the future of clinical operations from behind the scenes? Looking to be in the heart of a company where precision meets purpose?
Proclinical is seeking a Biomarker Clinical Operations Lead to provide operational expertise in biomarker and companion diagnostic sample management for clinical studies. This role involves planning, coordinating, and overseeing all operational activities related to biomarkers, ensuring quality data delivery and compliance with regulatory standards.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Provide operational expertise to clinical study teams for biomarker feasibility and data quality.
- Develop and execute the Biomarker Management Plan for drug and device studies.
- Manage biomarker operations activities, including vendor management and data quality assurance.
- Collaborate with internal and external stakeholders for sample collection, processing, and logistics.
- Lead vendor selection and oversight, ensuring quality and performance.
- Partner with Data Management to coordinate biomarker data delivery.
- Collaborate with cross-functional teams to execute operational strategies.
- Provide technical knowledge on biomarker analyses and regulatory compliance.
- Develop and oversee timelines, budgets, and risk management for biomarker analysis.
- Deliver presentations and training on biomarker procedures to stakeholders.
- Address biomarker-related queries from Health Authorities.
- Identify best practices and contribute to process improvements.
Key Skills and Requirements:
- Bachelor's or Master's degree in Life Sciences; further qualifications like a PhD or project management certification are advantageous.
- Experience in clinical research, laboratory, or pharmaceutical/biotechnology environments.
- Strong background in clinical development and team collaboration.
- Proficient in vendor and project management.
- Knowledge of drug development processes and regulations, including ICH and GCP guidelines.
- Experience with biological sample processing and analysis.
- Ability to work in a global, matrix environment.
- Excellent communication, collaboration, and problem-solving skills.
- Detail-oriented with the ability to manage multiple priorities.
- Fluency in English; additional languages are a plus.
If you are having difficulty in applying or if you have any questions, please contact Joshua Bye at j.bye@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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