Clinical Project Manager II – Biomarker Study Management
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Maine, Montana, Rhode Island, Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $95,000 - $175,700 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- 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.
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
- 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
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
- Company car or car allowance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biomarker study managementbioanalytical strategiessample collection workflowsoperational planningproject managementclinical trial lifecycledocumentation managementregulatory compliancefinancial managementdata analysis
Soft skills
communication skillsorganizational skillsproblem-solvingleadershipteam collaborationindependenceadaptabilityattention to detailstakeholder managementmeeting facilitation