Job Title:
Clinical Project Manager II – Biomarker Study Management
(Sponsor-Dedicated | Remote)
Updated: November 10, 2025
Location: USA–AR–Remote
Job ID: 25102536
About Syneos Health®
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success.
We combine clinical, medical affairs, and commercial insights to deliver impactful outcomes that meet modern healthcare needs.
With 29,000 employees across 110 countries, our mission is clear:
WORK HERE MATTERS EVERYWHERE.
Why Syneos Health
Commitment to career development, mentorship, and progression.
Supportive, engaged line management and technical training.
Total Self culture that values authenticity, inclusion, and belonging.
Recognition through peer awards, total rewards programs, and flexible benefits.
A diverse workplace that thrives on different perspectives and collaboration.
Position Overview
We are seeking a Clinical Project Manager II with biomarker study management expertise to lead and oversee global biomarker and bioanalytical operations.
This remote, sponsor-dedicated role will ensure smooth execution of biomarker strategies across multiple clinical phases (Phases I–IV).
You’ll work cross-functionally with study teams, vendors, and stakeholders to ensure accurate collection, tracking, and analysis of biological specimens, maintaining the highest operational and regulatory standards.
Key Responsibilities
1. Lead Biomarker Study Operations
Oversee biomarker and bioanalytical activities for sponsor and collaborative programs.
Serve as primary operational contact for all biomarker-related processes.
Integrate biomarker strategies into overall clinical development plans (Phases I–IV).
Plan and manage biological specimen collection, tracking, and analysis.
Advise study teams on sample management best practices and logistics.
2. Drive Clinical Project Delivery
Lead cross-functional teams through all phases — start-up to closeout.
Ensure timelines, budget, and quality targets are achieved.
Serve as main liaison between sponsors and study partners.
Monitor and manage project financials with fiscal accountability.
Identify and mitigate project risks and operational challenges proactively.
3. Ensure Operational Excellence
Maintain accurate and complete Trial Master File (TMF) documentation.
Keep study systems and databases current and audit-ready.
Prepare and deliver project status reports to sponsors and internal stakeholders.
Facilitate internal and external meetings to support study progress.
Support inspection readiness and ensure regulatory compliance.
Skills & Experience Required
Extensive experience managing biomarker studies and external vendors.
Strong understanding of biomarker and bioanalytical strategies in clinical trials.
Proven ability to manage sample logistics and complex analytical workflows.
Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing, or related field (or equivalent experience).
Previous experience in a CRO or sponsor environment preferred.
Familiarity with GCP, ICH guidelines, and global regulatory standards.
Strong project management, organizational, and communication abilities.
Independent, adaptable, and comfortable with digital tools and technologies.
Willingness to travel up to 25% as required.
Why Join Us
|
Benefit |
Description |
|---|---|
|
Meaningful Work |
Directly contribute to biomarker research shaping the future of precision medicine. |
|
Global Impact |
Engage in high-profile, multi-regional studies improving patient outcomes worldwide. |
|
Dedicated Team |
Collaborate in a sponsor-dedicated environment where expertise and innovation are valued. |
|
Flexibility |
Enjoy the autonomy of remote work with a strong, responsive support system. |
|
Career Growth |
Access continuous learning, leadership training, and advancement opportunities. |
|
Stability & Vision |
Join a trusted global organization recognized for operational excellence. |
Compensation & Benefits
Salary Range: $95,000 – $175,700 (based on qualifications and experience)
Benefits May Include:
Company car or allowance
Medical, Dental, and Vision insurance
401(k) with company match
Employee Stock Purchase Plan
Performance-based bonuses
Flexible paid time off (PTO) and sick leave
Compliance with state and federal paid leave regulations
About Syneos Health (At a Glance)
Partnered on 94% of FDA-approved novel drugs in the past 5 years.
Supported 95% of EMA-authorized products and over 200 studies globally.
Active across 73,000 sites and 675,000+ trial patients.
Committed to innovation, collaboration, and excellence in clinical research.
🌐 Learn more: www.syneoshealth.com
Additional Information
Responsibilities and tasks are not exhaustive; may vary based on business needs.
Equivalent experience, skills, and education will be considered.
Committed to compliance with the Americans with Disabilities Act and EU Equality Directive.
Dedicated to maintaining an inclusive, accessible recruitment process.
Core Focus Areas
Planning, directing, and communicating clinical study timelines.
Overseeing operational aspects of clinical trials.
Ensuring consistency across studies and adherence to SOP, GCP, and regulations.
Managing site and vendor selection and budget preparation.
Implementing clinical development and recruitment strategies.
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