Head of AI Transformation & Enablement leading AI initiatives at Novartis' Global Clinical Operations to drive AI adoption and operational excellence.
About the role
- Clinical Project Manager II managing biomarker studies for clinical trials at Syneos Health. Overseeing operations, ensuring project success, and providing leadership to cross-functional teams in a fully remote role.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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