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

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

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

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

We’re hiring a Clinical Project Manager II with a strong background in biomarker study operations to join our sponsor-dedicated team. This fully remote role gives you the opportunity to drive the success of global clinical trials by leading biomarker and bioanalytical strategy from start to finish.

You'll be a key player in bringing together cross-functional teams, vendors, and internal stakeholders to ensure biological samples are collected, managed, and analyzed to the highest standards.

What You’ll Do:

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

Skills and Experience You Bring:

• 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 manageme