Biomarker Operations - Senior Manager

Role Summary

The Biomarker Operations Senior Manager is a hands-on, execution-focused individual contributor responsible for the day-to-day delivery of biomarker sample operations across clinical studies. This role supports the implementation of established biomarker operational plans by executing defined workflows, maintaining accurate documentation, coordinating with vendors and internal teams, and resolving routine to moderately complex operational issues.

The successful candidate will demonstrate the ability to consistently follow established biomarker operational processes and procedures, apply them in real-world study execution, and provide feedback based on practical use rather than process design.

Responsibilities

• Independently execute biomarker sample operations activities, including sample tracking, shipping coordination, reconciliation, and lifecycle documentation, in accordance with study plans and SOPs
• Implement approved biomarker operational plans by following clinical protocols, laboratory manuals, sample management plans, and Data Transfer Agreements
• Coordinate with central laboratories, CROs, and internal study teams to ensure accurate and timely sample handling, receipt, and data delivery
• Maintain accurate operational trackers, logs, and documentation to support chain-of-custody, data integrity, and audit readiness
• Monitor routine operational activities, identify deviations or issues, investigate root causes within established procedures, and escalate findings with supporting data and recommended next steps
• Prepare operational summaries, trackers, and reports for review by senior biomarker operations leadership
• Support vendor oversight by tracking contracted deliverables, timelines, and invoices; follow up on discrepancies and support resolution
• Execute biomarker operational activities in alignment with established SOP laboratory manuals, and process documentation, and actively apply existing processes during study execution to identify gaps or issues for escalation
• Participate in study team and operational meetings to provide execution updates and respond to routine operational questions

Qualifications

• Required: Bachelor’s degree with typically 5 years of relevant experience in laboratory operations, clinical operations, biomarker operations, or other regulated operational environments, or an equivalent combination of education and experience
• Required: Experience executing operational processes in SOP-driven or regulated environments (e.g., GLP, GCP, GMP)
• Required: Demonstrated ability to operate within defined processes and governance while maintaining accountability for accurate and timely execution
• Required: Demonstrated ability to manage multiple routine but varied tasks independently
• Required: Strong documentation, organizational, and communication skills
• Required: Experience working with central laboratories to ensure proper sample receipt and shipment, and alignment on Laboratory Services Agreements and Manuals
• Required: Demonstrated ability to coordinate across cross-functional teams and external partners to drive operational activities to completion within defined timelines
• Required: Strong interpersonal skills to effectively collaborate with clinical, scientific, regulatory, and operational teams
• Preferred: Familiarity with project or operational tracking tools (e.g., Smartsheet or similar platforms)
• Preferred: Experience using Veeva systems to support operational documentation or workflows
• Preferred: Experience with Coupa or similar systems for invoice tracking and vendor-related activities