Sr. Clinical Trial Manager
Location: Morrisville, NC, USA | Job ID: 25102248 | Employment Type: Full-Time
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating drug development and improving patient outcomes. By combining clinical, regulatory, medical affairs, and commercial expertise, we deliver innovative solutions for modern healthcare challenges.
Our 29,000 employees across 110 countries collaborate in an inclusive, patient-centered, and highly professional environment, driving impact through innovation and scientific excellence.
Role Overview
The Sr. Clinical Trial Manager (Sr. CTM) oversees site management, clinical monitoring, and central monitoring for complex or large-scale studies. This role provides leadership, strategic direction, and mentorship to clinical operations teams, ensuring delivery of high-quality clinical trial management, compliance with regulatory standards, and achievement of project milestones.
Key Responsibilities
Lead site management, clinical monitoring, and central monitoring deliverables with focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
Oversee site interactions post-activation through site closeout, including patient recruitment, investigator payments, and other operational tasks.
Identify critical data, protocol execution risks, and implement mitigation strategies using the Risk Assessment and Categorization Tool (RACT).
Review study scope, budget, and protocol; communicate contractual obligations to clinical project teams.
Monitor operational performance, identify risks to timelines, quality, or budget, and escalate to project management as needed.
Act as a key escalation point for site staff communications, including investigator engagement and conflict resolution.
Collaborate with cross-functional leaders (Study Start-Up, Patient Recruitment, Data Management) to coordinate deliverables and ensure adherence to study milestones.
Maintain and optimize clinical study tools, dashboards, and templates; ensure access, audit trails, and system validation.
Provide initial and ongoing training for the study team on protocol requirements, SOPs, CRF completion, dashboards, and timelines.
Assess team resource allocations, performance, and compliance with study-specific processes; identify emerging risks and implement corrective action plans.
Review quality of site and central monitoring documentation to ensure accurate representation of site management activities and compliance with protocol/GCP standards.
Mentor and coach CTMs, CRAs, and central monitors to enhance functional clinical delivery and risk management.
Support inspection readiness and ensure all deliverables align with company, client, and regulatory expectations.
Qualifications & Experience
Bachelor’s degree or RN in a relevant field (or equivalent combination of education, training, and experience).
Proven expertise in site management and clinical/central monitoring in clinical trials.
Experience with risk-based monitoring and budget management.
Strong knowledge of Good Clinical Practice (GCP)/ICH guidelines and applicable regulatory requirements.
Demonstrated ability to lead and mentor teams, apply problem-solving techniques, and implement risk mitigation strategies.
Strong computer, communication, conflict resolution, and critical thinking skills.
Ability to work in an international environment; moderate travel (~20%) may be required.
Why Join Syneos Health
Lead and shape the execution of high-impact global clinical trials.
Collaborate with cross-functional teams and develop leadership and mentorship capabilities.
Access professional growth, career advancement, and a comprehensive benefits package, including health coverage, 401k match, flexible PTO, and performance-based bonuses.
Contribute directly to advancing patient care and innovative drug development.
Apply Now
Join Syneos Health as a Sr. Clinical Trial Manager and lead high-quality clinical operations, driving excellence in global drug development programs.
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