Julie Cyr
Sr Clinical Trial Manager @Syneos Health
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WORK HISTORY
Sr Clinical Trial Manager @Syneos Health
US
Provide oversight of site management, clinical monitoring, and central monitoring activities to ensure patient safety, protocol/GCP compliance, and data integrity.• Manage site interactions from activation through closeout, including patient recruitment and investigator payment processes.• Identify and mitigate operational risks using tools such as Risk Assessment and Categorization Tool (RACT).• Review study scope, budget, and protocol to ensure compliance with contractual obligations; escalate risks to timelines, quality, and budget.• Collaborate cross-functionally with Study Start-Up, Data Management, and Patient Recruitment teams to achieve key milestones (site activation, enrollment, database lock).• Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans; oversee system setup and user acceptance testing.• Coordinate training for study teams on protocol specifics, CRF completion, SOPs, and timelines.• Oversee CRA and Central Monitor resourcing, site assignments, and quality of deliverables; monitor progress using CTMS and dashboards.• Review monitoring documentation (visit reports, letters, central monitoring reports) for accuracy and compliance with protocol/GCP.• Serve as escalation point for site communications and conflict resolution; interact with investigators and site staff as needed.• Support inspection readiness and ensure compliance with SOPs, ICH GCP, and regulatory requirements.• Provide performance feedback to team members; coach and mentor Clinical Trial Managers on risk management and delivery strategies.
EDUCATION
The College of New Rochelle
B.S., Biology
University of Connecticut
MS, Biochemistry
University of Connecticut
M.S., Physiology
SKILLS
ABOUT JULIE CYR
With over 14 years of experience in clinical trial management across contract research organizations (CROs) and pharmaceutical settings I specialize in leading global clinical trials from initiation to close-out. My expertise spans a wide range of therapeutic areas, including oncology (CAR-T, leukemia, multiple myeloma, solid tumors), cardiovascular, NASH, and infectious diseases. I have a proven track record of strategic project oversight, risk mitigation, and stakeholder collaboration, ensuring that trials are executed on time, within budget, and in full compliance with regulatory standards (ICH/GCP, FDA). As a global trial leader, I have successfully managed complex studies across multiple countries, optimizing clinical operations, vendor management, patient recruitment, and data integrity. Experience within contract research organization (CRO) and sponsor environments, with an understanding of requirements necessary for early- and late-phase studies. Expertise therapeutic experience in a variety of clinical oncology settings, with areas of focus including Acute Lymphocytic & Myeloid Leukemia, Multiple Myeloma, Advanced Solid Malignancies, Lymphoma, Lung Cancer, and Renal Cancer. Additional therapeutic areas include cardiovascular, infectious disease, NASH, Respiratory, Vaccines, Immunology, GI, Dermatitis, Neurology Participated in RFPs, CRO, vendor and lab management. Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development and data management methods.Passionate about innovation in clinical research, I leverage data-driven insights to enhance trial efficiency, develop patient-centric strategies, and drive process improvements. Whether it\'s crafting FDA diversity plans, negotiating site incentives, or implementing technology-driven solutions to streamline workflows, my focus remains on delivering high-quality, impactful results. Let’s connect to discuss clinical research, project leadership, and advancing patient-centric solutions in the ever-evolving landscape of clinical trials! Feel free to reach out!
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