Clinical Trial Manager II

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Provide site management oversight, clinical monitoring and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity • Oversee site interactions from activation through closeout, including recruitment and investigator payments • Identify critical data, process and protocol execution risks and develop mitigations • Review study scope, budget and protocol content; communicate contractual obligations to CRAs and Central Monitors • Identify and escalate risks to timelines, quality, budget and contracted scope • Participate in and present at key meetings, including Kick Off Meetings • Serve as an escalation point for investigator site staff and interact with principal investigators and site staff by phone or in person • Coordinate with Study Start Up, Patient Recruitment and Data Management to achieve study milestones • Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan • Ensure CTMS, dashboards and other systems are configured, available and subject to required UAT and audit-trail reviews • Coordinate study-team training on protocols, CRF completion, dashboards, SOPs, plans and timelines • Oversee CRA and Central Monitor resourcing, site assignments, conduct, compliance and delivery risks • Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables • Review CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS and central monitoring dashboards to oversee site and patient activities • Oversee compliance with monitoring strategies, CMP/SMP and risk plans • Review site and central monitoring documentation for quality, compliance, patient safety, trial conduct and data integrity • Interact with clients, project management, leadership and functional departments; provide status updates and solutions • Support inspection readiness for clinical trial management • Oversee CRAs and Central Monitors, assess compliance and emerging risks, and support corrective action plans • Support activities to achieve data-cut and database-lock deadlines • Provide staff-performance feedback to line managers • May be assigned to larger, more complex trials

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Demonstrated ability to lead and align teams in the achievement of project milestones • Demonstrated capability of working in an international environment • Demonstrated expertise in site management and monitoring (clinical or central) • Preferred experience with risk-based monitoring • Understanding of clinical trial management financial principles and budget management • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills • Good communication, presentation and interpersonal skills among project team and with sites • Strong conflict resolution skills • Ability to apply problem-solving techniques to resolve complex issues and use a risk-management approach to identify and mitigate threats to successful clinical research projects • Critical thinking to determine causes and appropriate solutions when identifying issues • Moderate travel may be required, approximately 20%

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Total Self culture • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time

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