Biosample Operations Lead (50%)

Coopers Group AG seeks a Biosample Operations Lead (50%) in Basel to manage biosample logistics, vendor oversight, and protocol alignment for clinical trials.

This position acts as a key link within the Clinical Study Team, focusing on the operational planning and execution of biosample management. The role translates trial protocol requirements into actionable laboratory setups and ensures that sample handling processes align with clinical feasibility and study objectives.

Responsibilities

• Negotiate contracts and budgets with laboratory vendors while coordinating with internal stakeholders.
• Monitor and oversee all outsourced biosample activities to ensure compliance with trial plans.
• Create and maintain a Sample Chain of Custody, ensuring proper documentation is stored in the Trial Master File (TMF).
• Collaborate with clinical development, translational science, and pharmacokinetic teams to define analysis needs.
• Build and sustain productive relationships with clinical sites, vendors, and business partners.
• Identify potential risks in sample collection, delivery, and analysis, implementing mitigation strategies.
• Track follow-up items related to sample activities throughout clinical studies.
• Draft and review laboratory manuals to ensure they match the study protocol and clinical requirements.
• Manage sample delivery logistics, resolve queries, and negotiate with couriers to streamline shipments.
• Facilitate timely data delivery by coordinating sample shipments and query resolutions with vendors.
• Oversee biobank operations when applicable.
• Proactively identify issues and escalate urgent matters for rapid resolution.
• Track routine sample activities, including PK, PD, and Biomarkers, providing regular updates.
• Develop Biosample Operations SOPs, templates, and tools to standardize processes.
• Ensure all team activities comply with GxP regulations, GLP standards, and internal policies.

Requirements

• Degree in life sciences with at least six years of experience in the biotech or pharma sector.
• Significant experience in biosample operations management, particularly in securing chain of custody via outsourced vendors.
• Background in clinical or biological laboratories, with hands-on involvement in sample processing or analysis.
• Proven experience in clinical development, including monitoring studies or working at investigator sites.
• Strong critical reasoning abilities to solve complex problems independently and within teams.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Solid knowledge of Good Laboratory Practice (GLP) regulations.
• Excellent written and verbal communication skills.
• Experience in process design, procedural documentation, and leading process improvements.

What the company offers

• Contract duration until December 31, 2026, with the possibility of extension.
• 50% workload.
• Based in Basel, Switzerland.

About the company

Coopers Group AG fosters a collaborative and innovative work environment, encouraging teamwork and creative problem-solving across its operations.

• Promotes a collaborative atmosphere among team members.
• Encourages innovation in daily workflows and project execution.