Manager II Biospecimen Lead

Manager II Biospecimen Lead will oversee biospecimen management across 5-12 clinical trials while developing specimen management plans, coordinating with vendors, and providing regular status updates to clinical teams. This independent contributor role requires managing complex timelines, ensuring regulatory compliance, and optimizing biospecimen workflows.

Responsibilities

• Develop specimen management plans identifying risks and mitigation strategies for clinical trials
• Track and reconcile biospecimen status across internal and external systems with vendor coordination
• Enter biospecimen requirements into contracting systems and align vendor documentation with protocols
• Provide regular biospecimen status updates to clinical teams regarding inventory, quality, and timelines
• Participate in vendor audits, CAPA resolutions, and cross-functional optimization projects

Requirements

• Intermediate knowledge of clinical biospecimen procedures, collection, tracking, and chain of custody
• Intermediate vendor management experience with central labs, bioanalytical, or biospecimen storage vendors
• 3+ years pharmaceutical, biotech, healthcare, or academic industry experience
• Scientific degree (Associate's, Bachelor's, Master's, or higher) or equivalent project management experience
• Basic understanding of GCP, GLP, CLIA, data management, and regulatory issues
• Ability to manage 5-12 trials simultaneously and effectively prioritize tasks
• Strong communication and presentation skills with limited supervision

Compensation: zł194,000 - zł235,087