Clinical Project Manager II – Biomarker Study Management

Syneos Health

Clinical Project Manager II overseeing biomarker study operations at Syneos Health. Leading global clinical trials by integrating biomarker and bioanalytical strategy across teams.

Posted 6/6/2026full-timeFoster City • Arizona, California, Maine, Ohio, Rhode Island • 🇺🇸 United StatesMid-LevelSenior💰 $95,000 - $175,700 per yearWebsite

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Hard Skills

biomarker study managementbioanalytical strategiessample collection workflowssample logisticsproject financial managementdocumentation managementclinical trial lifecycleregulatory complianceGCPICH guidelines

Soft Skills

project managementorganizational skillscommunication skillsproblem-solvingteam leadershipindependent workadaptabilitystakeholder engagementmeeting facilitationfiscal responsibility

Tools & Technologies

Trial Master File (TMF)clinical study systemsdatabasesproject management softwareaudit readiness toolsbiological specimen tracking systemscollaborative platformsreporting toolsdata analysis softwareregulatory compliance systems

Industry Keywords

clinical research organization (CRO)biomarkerclinical trialslife sciencesmedicinepharmacynursingsample managementoperational planningglobal regulatory standards

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
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

What you’ll need

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

Comp & perks

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