Global Clinical Trial Manager II, Solid CRA Background

🔥 1 minute ago

🌐 United Kingdom, Poland, +2 more countries – Remote

🇬🇧 United Kingdom – Remote 🇵🇱 Poland – Remote 🇪🇸 Spain – Remote 🇧🇬 Bulgaria – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 10%

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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 • Ensure patient safety, protocol/GCP/regulatory compliance and data integrity • Oversee site interactions from activation through closeout, including recruitment and investigator payments • Identify clinical trial risks and develop risk mitigations • Review study scope, budget, protocol content and contractual obligations • Escalate timeline, quality, budget and out-of-scope risks to the project manager • Participate in and present at key meetings, including Kick Off Meetings • Serve as an escalation point for investigator site communications and support site observations or conflict resolution • 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 Clinical Monitoring Plans • Ensure CTMS, dashboards and other systems are configured, tested and maintained • Coordinate study-team training on protocols, CRFs, dashboards, SOPs, plans and timelines • Oversee CRA and Central Monitor resourcing, assignments, conduct and delivery risks • Review monitoring documentation, dashboards and clinical trial systems for quality, compliance and timely execution • Oversee compliance with monitoring strategies, CMP/SMP and risk plans • Provide status updates, risk reporting and solutions to clients, project management and leadership • Support inspection readiness, corrective action plans, data cuts and database lock activities • Oversee CRAs and Central Monitors and provide performance feedback to line managers

🎯 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 achievement of project milestones • Capability to work in an international environment • Expertise in site management and clinical or central monitoring • 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 • Strong conflict resolution skills • Ability to apply problem-solving techniques to resolve complex issues and use a risk-management approach • Critical thinking to identify issues, determine causes and select appropriate solutions • Fully home based in the UK, Poland, Spain or Bulgaria • Moderate travel may be required, approximately 20%

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Moderate travel opportunity (approximately 20%)