Clinical Project Manager II - Biomarker Study Management

Role Description

We’re hiring a Clinical Project Manager II with a strong background in biomarker study operations to join our sponsor-dedicated team. This fully remote role gives you the opportunity to drive the success of global clinical trials by leading biomarker and bioanalytical strategy from start to finish.

You'll be a key player in bringing together cross-functional teams, vendors, and internal stakeholders to ensure biological samples are collected, managed, and analyzed to the highest standards.

What You’ll Do:

• Lead Biomarker Study Operations
  • 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
• Drive Clinical Project Delivery
  • 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
• Ensure Operational Excellence
  • 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

Qualifications

• 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
• Experience in a clinical research organization (CRO) or sponsor environment preferred
• Familiarity with GCP, ICH guidelines, and global regulatory standards
• Strong project management, organizational, and communication skills
• Comfortable working independently and embracing new technologies
• Willingness to travel up to 25% as needed

Benefits

• Meaningful Work: Your contributions will directly support critical biomarker research that shapes the future of clinical development and precision medicine.
• Global Impact: You'll be working on high-profile studies that span multiple regions, making a real difference in patients’ lives around the world.
• Dedicated Team: Join a collaborative, sponsor-dedicated environment where your expertise is trusted, and your voice matters.
• Flexibility: Enjoy the freedom of a fully remote role with the support of a structured, responsive team.
• Professional Growth: Be part of a company that invests in your career through continued learning, mentorship, and leadership opportunities.
• Stability and Vision: Work with a leading global organization known for operational excellence and long-term partnerships in clinical research.