Site Monitoring Lead, Germany

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🔥 5 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

👻 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 focused on patient safety, protocol/GCP/regulatory compliance, and data integrity • Oversee site interactions from post-activation through site closeout, including patient recruitment and investigator payments • Identify clinical trial management risks and develop or implement mitigations • Review study scope of work, budget, and protocol content; ensure CRAs/CeMs understand 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 staff communications and accompany CRAs to sites when needed • Coordinate 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; oversee UAT and access/audit trail reviews • Coordinate study-team training on protocols, CRFs, dashboards, SOPs, plans, data requirements, and timelines • Oversee CRA and Central Monitor resourcing, assignments, conduct, quality, and delivery • Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards • Ensure monitoring strategy, CMP/SMP, and risk-plan compliance • Review site and central monitoring documentation and ensure timely delivery and appropriate risk communication • Provide client, project management, and leadership status updates on deliverables and risks • Support inspection readiness for clinical trial management activities • Oversee CRAs and Central Monitors, assess compliance, identify emerging risks, and support corrective action plans • Support activities required to achieve data cut and database lock deadlines • Provide performance feedback to line managers • Coordinate clinical activities for CTM teams on larger or more complex trials • Coach and mentor CTMs on clinical delivery, project risks, and action implementation

🎯 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 • Experience in oncology is an asset • 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 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 • Remote work (pre-approved)