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

Syneos Health, Inc•Morrisville, NC

44d•$95,000 - $175,700•Remote

About The Position

Clinical Project Manager II - Biomarker Study Management (Sponsor-Dedicated | Remote) 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 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 accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE 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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. 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. If you're passionate about clinical research and want to make a direct impact on advancing biomarker science, we'd love to hear from you. Apply now and be part of a team shaping the future of clinical development. Atâ¯ 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. Get to know Syneos Health 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. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com 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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles 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

Requirements

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
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

Nice To Haves

Experience in a clinical research organization (CRO) or sponsor environment preferred

Responsibilities

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
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
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

Benefits

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
flexible paid time off (PTO) and sick time

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