Clinical Trial Manager – Single Sponsor

4 hours ago

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Syneos Health

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Biotechnology • Pharmaceuticals • Healthcare Insurance

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.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity • Oversees site interactions post activation through site closeout • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT) • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations • Participates and presents in key meetings such as Kick Off Meeting • Serves as an escalation point for communications with investigator site staff • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintains proper visibility of its progress by the use of approved systems and/or tracking tools • Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan • Reviews the content and quality of site and central monitoring documentation to ensure they represent site management activities and conduct

🎯 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 • Demonstrates understanding of clinical trial management financial principles and budget management • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Must demonstrate good computer skills • Good communication, presentation and interpersonal skills among project team and with sites • Fluency in German • Strong conflict resolution skills • Demonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of 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 and total rewards program