Clinical Trial Manager – Single Sponsor

🔥 0 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 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

• Manage site 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, investigator payments, and related activities • Identify clinical trial risks and implement risk mitigations • Review study scope, budget, protocol content, and contractual obligations with the clinical project team • 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 interact with principal investigators and site staff • Coordinate delivery handoffs with Study Start Up, Patient Recruitment, and Data Management teams • Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans • Ensure CTMS, dashboards, and other systems are configured and available, including overseeing UAT and audit trail reviews • Coordinate study-team training on protocols, CRFs, dashboards, SOPs, plans, data, and timelines • Oversee CRA and Central Monitor resourcing, site assignments, conduct, and delivery risks • Monitor quality and progress of clinical monitoring, central monitoring, and site management deliverables • Review clinical trial systems and dashboards, including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS, and central monitoring dashboards • Oversee 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 on deliverables and risks • Support inspection readiness, corrective action plans, data cuts, and database lock deadlines • 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 achieving 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 applicable regulatory requirements • Good computer skills • Good communication, presentation and interpersonal skills • Strong conflict resolution skills • Fluency in both German and English • Ability to apply problem-solving techniques to resolve complex issues and use a risk-management approach • Critical-thinking ability to identify issues and determine appropriate solutions • Approximately 20% travel may be required

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture supporting authenticity and belonging • Diversity, inclusion and belonging initiatives