Clinical Project Manager Ii – Biomarker Study Management (Sponsor-Dedicated | Remote)

0-2 years

$95,000 – $175,700

Remote, USA

10 Nov. 12, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧬 Job Title: Clinical Project Manager II – Biomarker Study Management

Type: Sponsor-Dedicated | Remote
Location: USA – PR – Remote
Updated: November 10, 2025
Job ID: 25102536
Company: Syneos Health®

🌍 About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
The company combines clinical development, medical affairs, and commercial expertise to bring life-changing therapies to patients faster.

With 29,000 employees across 110 countries, Syneos Health partners with pharmaceutical and biotechnology clients to streamline operations and deliver impactful results.

Motto: Work Here Matters Everywhere.

💡 Our Culture & Commitment

Career Growth: Robust development and progression opportunities
Inclusive Environment: “Total Self” culture encouraging authenticity
Learning & Recognition: Training, peer recognition, and total rewards program
Diversity: A workplace built on varied perspectives, backgrounds, and experiences
Supportive Leadership: Engaged line management and mentorship opportunities

🎯 Position Overview

The Clinical Project Manager II – Biomarker Study Management is responsible for leading biomarker and bioanalytical operations in global clinical trials.
This fully remote, sponsor-dedicated position integrates scientific and operational expertise to ensure successful delivery of biomarker components within clinical development programs (Phases I–IV).

⚙️ Key Responsibilities

1. Biomarker Study Operations

Oversee biomarker and bioanalytical activities across sponsor and collaboration programs.
Act as the operational point of contact for biomarker-related processes.
Collaborate with clinical study teams to integrate biomarker strategies into broader clinical development plans.
Manage the collection, tracking, storage, and analysis of biological specimens.
Provide expert advice on sample logistics, handling, and documentation best practices.

2. Clinical Project Delivery

Lead cross-functional project teams through start-up, execution, and closeout.
Ensure adherence to timelines, budgets, scope, and quality standards.
Serve as the main liaison between sponsor and vendors.
Track and manage project financials ensuring fiscal responsibility.
Identify, assess, and mitigate operational risks proactively.

3. Operational Excellence

Maintain Trial Master File (TMF) accuracy and audit readiness.
Update study databases and ensure regulatory documentation compliance.
Prepare progress reports, presentations, and updates for internal and sponsor review.
Organize and facilitate internal and external meetings.
Ensure inspection readiness and compliance with global regulatory standards.

🧩 Required Skills & Experience

Strong experience managing biomarker studies and external vendors.
In-depth understanding of biomarker and bioanalytical strategies within clinical research.
Demonstrated success in managing complex sample collection and analysis workflows.
Bachelor’s degree (or higher) in Life Sciences, Medicine, Pharmacy, or Nursing.
Familiarity with Good Clinical Practice (GCP), ICH Guidelines, and global regulations.
Excellent project management, communication, and organizational skills.
Tech-savvy and capable of working independently in a remote setup.
Willingness to travel up to 25% as required.

🌟 Preferred Qualifications

Prior experience in a Clinical Research Organization (CRO) or Sponsor environment.
Advanced understanding of clinical data management and operational systems.

🚀 Why Join Us

Meaningful Work: Contribute directly to advancing precision medicine and biomarker research.
Global Impact: Manage high-profile, multi-regional biomarker studies that improve patient outcomes.
Collaboration: Work in a trusted, sponsor-dedicated team that values expertise and communication.
Remote Flexibility: Enjoy work-from-home freedom with full organizational support.
Growth & Learning: Access to continuous learning, mentoring, and leadership pathways.
Stability: Be part of a global organization with proven operational excellence and vision.

💰 Compensation & Benefits

Salary Range: $95,000 – $175,700 (based on qualifications and experience)

Benefits Include:

Company car or car allowance
Comprehensive Medical, Dental, and Vision coverage
401(k) with company match
Employee Stock Purchase Plan (ESPP) eligibility
Bonus/Commission opportunities based on performance
Flexible Paid Time Off (PTO) and regulated sick leave

🧾 Additional Information

Duties listed are not exhaustive and may evolve as per business needs.
Equivalent education, training, or experience may substitute listed qualifications.
Syneos Health complies with all EEO, ADA, and EU Equality Directive regulations.
Reasonable accommodations will be provided for qualified applicants.

🧠 Core Focus Areas

Planning and communicating clinical study timelines
Overseeing operational and regulatory aspects of trials
Ensuring consistency across clinical programs
Managing site and vendor selection
Budget preparation and financial monitoring
Implementing clinical development and recruitment strategies
Maintaining SOP and GCP compliance

🎯 Role Impact

The Clinical Project Manager II plays a pivotal role in ensuring efficient execution of biomarker-driven clinical trials.
By driving quality, compliance, and delivery excellence, this role supports the advancement of precision medicine and accelerates global therapeutic innovation.

🔗 How to Apply

👉 Apply Now to join Syneos Health and shape the future of clinical development.
📩 Not ready yet? Join our Talent Network to stay connected for future opportunities.

🌐 Learn more: www.syneoshealth.com

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Clinical Project Manager Ii – Biomarker Study Management (Sponsor-Dedicated | Remote)

Job Description

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