Syneos Health is seeking a Clinical Project Manager II to specialize in biomarker study management for a sponsor-dedicated team. In this fully remote role, you will drive the success of global clinical trials by leading biomarker and bioanalytical strategy from start to finish, integrating with clinical study teams and managing cross-functional stakeholders.
What You'll Do
- 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.
What We're Looking For
- Significant experience managing biomarker studies and external vendors.
- 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.
- 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.
Nice to Have
- Experience in a clinical research organization (CRO) or sponsor environment.
Team & Environment
You will join a sponsor-dedicated team, working in a cross-functional collaborative environment.
Benefits & Compensation
- 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.
- Potential company car or car allowance.
Work Mode
This is a fully remote position.
Syneos Health is passionate about developing our people through career development, supportive management, and training. We are committed to a Total Self culture where you can authentically be yourself and are dedicated to diversity, inclusion, and creating a place where everyone feels like they belong.
