Description
Clinical Project Manager - Biomarker Study Management Experience required (Sponsor Dedicated - US Remote; Preference for Hybrid Foster City, CA)

Job Responsibilities

• Clinical Project Manager II - Biomarker Study Management
  Sponsor-Dedicated | Remote
  
  (Preference for Hybrid Foster City, CA-Based Candidates)
  
  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.
  
  While remote/home-based candidates may be considered, priority will be given to candidates located within 50 miles Foster City, California, with the ability to work onsite 2-3 days per week.
  
  WHAT YOU WILL 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

If you're passionate about clinical research and want to make a direct impact on advancing biomarker science with your expertise, we'd love to hear from you.

** Candidates without direct experience supporting Biomarker clinical trials can not be considered.**
WHY JOIN US

Meaningful Work: Your contributions will directly support critical biomarker research that shapes the future of clinical development and precision medicine.

Global Impact: You'll be working on high-profile studies that span multiple regions, making a real difference in patients' lives around the world.

Dedicated Team: Join a collaborative, sponsor-dedicated environment where your expertise is trusted, and your voice matters.

Professional Growth: Be part of a company that invests in your career through continued learning, mentorship, and leadership opportunities.

Stability and Vision: Work with a leading global organization known for operational excellence and long-term partnerships in clinical research.

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 management, organizational, and communication skills

Comfortable working independently and embracing new technologies

Willingness to travel up to 25% as needed

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

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

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, 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, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Summary
oles within Clinical Project Management job family at the M23 level are responsible for planning, directing, creating, and communicating clinical study timelines. These roles gather input from cross-functional teams to create plans that help the team produce deliverables on schedule. They ensure consistency of clinical study and processes across clinical trials, overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. Responsibilities include site and vendor selection, preparing clinical trial budgets, and ensuring studies are conducted within clinical trial protocols. These roles also involve monitoring progress and following up with team members and line managers when issues develop. Additionally, they implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies. Impact and Contribution Roles within Clinical Project Management job family at the M23 level significantly impact the success of clinical trials by ensuring that all aspects of the study are conducted efficiently and effectively. By gathering input from cross-functional teams and creating detailed plans, these roles help ensure that deliverables are produced on schedule, contributing to the overall success of the clinical trials. Their oversight of operational aspects of clinical trials ensures consistency and adherence to SOP, GCP, and country regulations, which is crucial for the integrity and reliability of the study results. Additionally, their involvement in site and vendor selection, budget preparation, and monitoring progress helps maintain the smooth operation of clinical trials, ultimately contributing to the advancement of clinical research and development. Core Focus • Planning, directing, creating, and communicating clinical study timelines • Overseeing operational aspects of clinical trials • Ensuring consistency across clinical studies • Adhering to SOP, GCP, and country regulations • Selecting sites and vendors • Preparing clinical trial budgets • Monitoring progress and following up with team members and line managers • Implementing and preparing the clinical development strategy • Developing trial recruitment strategies