Clinical Trial Manager I

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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

• Oversee site management, 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 patient recruitment and investigator payments where applicable • Identify clinical trial management risks and develop or implement risk mitigations • Review study scope of work, budget and protocol content; ensure the clinical project team understands contractual obligations and parameters • Escalate risks to timelines, quality, budget and out-of-scope activities to the project manager • Participate in and present at key meetings, including Kick Off Meetings • Serve as an escalation point for investigator site staff communications and interact with principal investigators and site staff • Collaborate with Study Start Up, Patient Recruitment, Data Management and other functional leaders to meet study milestones • Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan • Ensure CTMS, dashboards and other systems are configured and available, including overseeing UAT as needed • Coordinate initial and ongoing study-team training • Oversee CRA and Central Monitor resourcing, site assignments, conduct and delivery risks • Monitor quality and visibility of clinical monitoring, central monitoring and site management deliverables using approved systems and tracking tools • Review CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS and central-monitoring dashboards to oversee site and patient activities • Ensure compliance with the monitoring strategy, CMP/SMP and risk plans • Review site and central monitoring documentation for quality, completeness and risks to compliance, patient safety and data integrity • Interact with clients and functional departments regarding clinical monitoring and site management deliverables • Provide status updates on clinical deliverables and risks to clients, project management and leadership • Support inspection readiness, corrective action plans, data cut and database lock activities • Oversee assigned CRAs and Central Monitors and assess process, training and CMP compliance • Provide performance feedback to line managers

🎯 Requirements

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience • Ability to lead and align teams to achieve project milestones • Ability to work in an international environment • Previous clinical trial experience in site management • Preferred experience with risk-based monitoring and clinical or central monitoring • Familiarity with financial principles and budget management practices • Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements • Good computer skills • Good communication, presentation and interpersonal skills • Basic conflict resolution skills • Problem-solving and risk-management ability for complex clinical research issues • Critical-thinking ability to identify causes and appropriate solutions • Moderate travel availability, approximately 20%

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Collaboration with specialized therapeutically or functionally aligned teams • Diverse career paths and employment opportunities • Reasonable accommodations, when appropriate