Clinical Trial Manager I
Location: Remote – New Jersey, USA | Job ID: 25104602 | Employment Type: Full-Time
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating drug development and improving patient outcomes. We combine clinical, medical affairs, and regulatory expertise to provide innovative solutions for modern healthcare challenges.
With 29,000 employees across 110 countries, Syneos Health fosters a collaborative, inclusive, and professional environment, where innovation, scientific rigor, and patient-centric focus drive every project.
Role Overview
The Clinical Trial Manager I (CTM I) serves as the clinical functional lead, overseeing site management, clinical monitoring, and central monitoring for assigned study(ies). This role ensures compliance with protocol, GCP, regulatory standards, and project timelines while managing and mentoring clinical and central monitoring team members. The CTM I may also serve as a regional lead on larger trials under a senior CTM.
Key Responsibilities
Lead and oversee site management, clinical monitoring, and central monitoring activities, ensuring patient safety, protocol compliance, data integrity, and regulatory adherence.
Manage site interactions post-activation through closeout, including patient recruitment and investigator payments.
Identify critical data, protocol execution risks, and implement risk mitigation strategies using the Risk Assessment and Categorization Tool (RACT).
Monitor study scope, budget, and protocol adherence; escalate risks to project management as needed.
Participate and present in key meetings, including Kick-Off and cross-functional team meetings.
Serve as an escalation point for site communications, including investigator interactions and conflict resolution.
Collaborate with other functional leads, such as Study Start-Up, Patient Recruitment, and Data Management, to meet study milestones.
Maintain and oversee clinical study tools, dashboards, and templates, ensuring proper access, audit trails, and UAT completion.
Provide training to the study team on protocol specifics, SOPs, CRF completion, dashboards, and timelines.
Allocate and oversee resources, assess team conduct, and identify risks to delivery or quality.
Review and ensure the quality of site and central monitoring documentation, ensuring risks are properly communicated.
Provide technical support, mentoring, and guidance to clinical operations staff.
Support inspection readiness for clinical trial management scope and maintain compliance with all applicable regulations and SOPs.
Qualifications & Experience
Bachelor’s degree or RN in a related field (or equivalent combination of education, training, and experience).
Previous clinical trial experience in site management and clinical/central monitoring.
Familiarity with risk-based monitoring, budget management, and financial principles.
Strong knowledge of Good Clinical Practice (GCP)/ICH guidelines and other regulatory requirements.
Demonstrated leadership, problem-solving, and team management skills.
Excellent communication, presentation, interpersonal, and conflict resolution skills.
Ability to work in international environments and apply risk management strategies to clinical trial challenges.
Moderate travel may be required (~20%).
Why Join Syneos Health
Lead the execution of global clinical trials in a dynamic and collaborative environment.
Develop leadership and mentorship skills while working with cross-functional teams.
Access professional development, career progression opportunities, and comprehensive employee benefits including health coverage, 401k match, flexible PTO, and potential bonuses.
Contribute directly to clinical trial success, impacting patient care and drug development globally.
Apply Now
Join Syneos Health as a Clinical Trial Manager I and play a critical role in delivering high-quality clinical operations for global drug development programs.
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