Clinical Project Manager II – Biomarker Study Management (Sponsor-Dedicated | Remote)

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. They are seeking a Clinical Project Manager II to lead biomarker study operations and drive the success of global clinical trials by managing biomarker and bioanalytical strategies.

Responsibilities:

• Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs
• Serve as the operational point of contact for all biomarker-related processes
• Work closely with clinical study teams (Phases 1–4) to integrate biomarker strategies into broader clinical development plans
• Plan and manage the collection, tracking, and analysis of biological specimens
• Advise study teams on best practices for sample management and logistics
• Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout
• Ensure studies stay on track with respect to timelines, budget, scope, and quality
• Act as the main liaison between the sponsor and study partners
• Monitor and manage project financials, ensuring fiscal responsibility
• Proactively identify and resolve operational issues and risks
• Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness
• Keep study systems and databases current and audit-ready
• Prepare project reports and updates for sponsors and internal stakeholders
• Plan and facilitate internal and external meetings
• Support inspection readiness and regulatory compliance throughout the project

Requirements:

• Significant experience managing biomarker studies and external vendors required!
• Strong understanding of biomarker and bioanalytical strategies in a clinical trial setting
• Proven ability to coordinate complex sample collection and analysis workflows
• Expertise in supporting study teams with sample logistics and operational planning
• Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing, or equivalent combination of education and experience
• Strong project management, organizational, and communication skills
• Comfortable working independently and embracing new technologies
• Willingness to travel up to 25% as needed
• Experience in a clinical research organization (CRO) or sponsor environment preferred
• Familiarity with GCP, ICH guidelines, and global regulatory standards