Biomarker Imaging Operations Manager

Overview

• Manage operational execution of biomarker and imaging strategies for clinical trials.
• Collaborate cross-functionally to ensure high-quality data delivery for regulatory submissions.
• Oversee vendor selection, contracting, and management for biomarker and imaging services.
• Ensure compliance with biospecimen handling regulations and ethical standards.
• Support database lock and clinical study report activities.
• Contribute to process improvement and best practice creation for biomarker operations.
• Provide feedback on vendor performance and manage risk mitigation strategies.
• Collaborate with Clinical Development to align operational plans with scientific objectives.
• Lead cross-functional teams to integrate biomarker activities into overall study execution.

Key Responsibilities & Duties

• Implement biomarker and imaging components in clinical trials from start-up to closeout.
• Develop and review study documents including protocols and laboratory manuals.
• Monitor timelines, budgets, and deliverables for biomarker and imaging activities.
• Ensure timely collection, processing, and analysis of biological samples.
• Manage imaging acquisition, standardization, and data transfer processes.
• Collaborate with Data Management to ensure data standards and analysis readiness.
• Provide operational oversight for vendor performance and contractual compliance.
• Support site training and study start-up activities for biomarker operations.
• Execute risk management strategies for biomarker and imaging activities.

Job Requirements

• Bachelor’s degree in Life Sciences, Biomedical Engineering, or related field required.
• Minimum 5 years of experience in biomarker or clinical trial operations.
• Hands-on experience managing central laboratories and imaging vendors.
• Knowledge of biospecimen lifecycle management and imaging modalities.
• Understanding of regulatory requirements including FDA, EMA, and ICH-GCP.
• Proficiency in project management tools and budget tracking.
• Strong organizational, problem-solving, and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Familiarity with biomarker assay development and validation is preferred.