Clinical Trial Manager – Single Sponsor

🔥 1 hour 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

• 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 scope of work, budgets and protocols; ensure clinical project teams understand contractual obligations • Identify and escalate risks affecting 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 interact with investigators and site staff • Collaborate with Study Start Up, Patient Recruitment, Data Management and other functions to meet study milestones • Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans • Ensure CTMS, dashboards and other systems are configured and available, including UAT and access/audit trail reviews • Coordinate training on protocols, CRF completion, dashboards, SOPs, clinical plans, data plans and timelines • Oversee CRA and Central Monitor resourcing, site assignments, conduct and delivery risks • Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables • Review CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS and monitoring dashboards for timely operational execution • Ensure assigned clinical team members understand and comply with monitoring strategies, plans and risk controls • Review monitoring documentation and ensure revisions, approvals and delivery deadlines are met • Provide status updates and solutions to clients, project management and leadership • Support inspection readiness, corrective action plans, data cuts and database lock deadlines • Provide 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 • 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 • Inclusive culture