Global Clinical Trial Manager II

🔥 4 minutes ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 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, 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; ensure the clinical project team understands contractual obligations • 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 communications and support site visits as needed • Coordinate handoffs with Study Start Up, Patient Recruitment and Data Management to meet study milestones • Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans • Ensure CTMS, dashboards and related 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 • Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables • Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePRO, TMF and IVRS/IWRS • Ensure team compliance with monitoring strategies, CMP/SMP and risk plans • Review site and central monitoring documentation and ensure timely revisions, approvals and delivery • Provide client, project management and leadership status updates, risks and solutions • Support compliance with protocol, SOPs, ICH GCP and country regulations, including inspection readiness • Oversee CRAs and Central Monitors, assess compliance 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 • Strong conflict resolution skills • Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach • Critical thinking to determine causes and appropriate solutions • 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 • Reasonable accommodations when appropriate