Biomarker And Imaging Operations Manager

Overview

• Manage biomarker and imaging operations for clinical trials, ensuring successful implementation and high-quality data delivery.
• Collaborate cross-functionally with clinical teams, regulatory affairs, and external vendors to meet study objectives.
• Oversee biomarker and imaging strategies from study start-up through closeout, ensuring compliance with regulations.
• Develop and review study documents, including protocols, laboratory manuals, and imaging charters.
• Monitor timelines and budgets for biomarker and imaging data collection and analysis.
• Ensure biospecimen handling compliance and ethical standards are maintained throughout the study.
• Support data reconciliation and contribute to database lock and clinical study report activities.
• Drive continuous improvement in processes, templates, and best practices for biomarker and imaging operations.

Key Responsibilities & Duties

• Lead operational implementation of biomarker and imaging components in clinical trials.
• Manage central laboratories, imaging vendors, and specialty assay providers, ensuring timely deliverables.
• Collaborate with Clinical Operations to integrate biomarker and imaging activities into study execution.
• Develop site training materials and participate in study start-up training sessions.
• Ensure compliance with GCP and applicable regulations, managing risk and mitigation strategies.
• Monitor vendor performance, escalate findings, and provide feedback to stakeholders.
• Establish sample lifecycle tracking and chain-of-custody procedures.
• Support biomarker and imaging data reconciliation and analysis readiness.

Job Requirements

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Medical Imaging, or related field.
• 5+ years in biomarker, imaging, or clinical trial operations, preferably within biotech or pharmaceutical environments.
• Experience managing central laboratories and imaging vendors, with knowledge of biospecimen lifecycle management.
• Familiarity with imaging modalities such as MRI, CT, and PET, and regulatory requirements like FDA and EMA.
• Proficiency in project management tools, budget tracking, and data standards like CDISC.
• Strong organizational, problem-solving, and cross-functional collaboration skills.
• Effective communication and presentation abilities to manage multiple priorities in a fast-paced environment.
• Understanding of biomarker assay development and validation is highly desirable.