Job Description
Clinical Project Manager II Biomarker Study Management (Sponsor-Dedicated | Remote) Clinical Project Manager II Biomarker Study Management (Sponsor-Dedicated | Remote) Updated: November 10, 2025 Location: USA-MA-
Remote Job : Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do.
We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a FullService environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Responsibilities • Lead biomarker and bioanalytical study operations across sponsor and collaborative programs.
• Serve as the operational point of contact for all biomarkerrelated processes. • Work closely with clinical study teams (Phases 14) 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. • Lead crossfunctional teams through the full clinical trial lifecycle, from startup 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. • Maintain highquality documentation, including Trial Master File (TMF) accuracy and completeness. • Keep study systems and databases current and auditready. • 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.
Qualifications • Significant experience managing biomarker studies and external vendors. • 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. • Bachelors 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 • Meaningful work : contributions directly support critical biomarker research. • Global impact: highprofile studies spanning multiple regions. • Dedicated team: collaborative, sponsordedicated environment. • Flexibility: fully remote role with structured, responsive team support.
• Professional growth : learning, mentorship, leadership opportunities. • Stability and vision: leading global organization known for operational excellence. If youre passionate about clinical research and want to make a direct impact on advancing biomarker science, wed love to hear from you. and be part of a team shaping the future of clinical development. Salary Range $95,000.00 - $ Company Impact Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Equal Opportunity Employer Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email:.
One of our staff members will work with you to provide alternate means to. Phone: Fax: Toll-Free: #J-18808-Ljbffr Apply tot his job