Clinical Trial Manager, dedicated

🔥 3 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Logo of Syneos Health

Syneos Health

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 • Focus on patient safety, protocol/GCP/regulatory compliance, and data integrity • Oversee site interactions from activation through closeout, including recruitment and investigator payments when applicable • Identify clinical trial risks and develop or implement mitigations, including RACT-related risks • 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 accompany CRAs to sites when needed • Coordinate with Study Start Up, Patient Recruitment, Data Management, and other functions 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 UAT and audit trail reviews • Coordinate protocol, CRF, dashboard, SOP, clinical plan, data plan, and timeline training for study teams • Oversee CRA and Central Monitor resourcing, assignments, conduct, compliance, and deliverable quality • Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards • Ensure monitoring strategy, CMP/SMP, risk plans, and protocol requirements are understood and followed • Review site and central monitoring documentation and ensure timely, compliant delivery • Provide client, project management, and leadership status updates on deliverables and risks • Support inspection readiness, corrective action plans, data cuts, and database lock deadlines • Provide staff performance feedback to line managers • Coordinate clinical activities across portfolios and mentor CTMs when assigned

🎯 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 • Strong conflict resolution skills • Ability to apply problem-solving techniques to resolve complex issues and use a risk management approach • 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 • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate

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