Job Title:
Clinical Trial Manager I
Company:
Syneos Health
A global leader in integrated biopharmaceutical solutions, Syneos Health accelerates customer success by providing unique insights in clinical, medical affairs, and commercial strategies.
Location:
Germany (Europe)
Job ID:
25003425-DEU
Updated:
Today
Job Summary:
The Clinical Trial Manager I will oversee site management, clinical monitoring, and risk management for clinical trials. This role ensures compliance with regulatory standards, manages trial progress, and mitigates risks, collaborating with teams to meet key study milestones.
Key Responsibilities:
Oversee site management, clinical monitoring, and central monitoring with an emphasis on patient safety, protocol compliance, and data integrity.
Manage site interactions from activation through to closeout, including recruitment and investigator payments.
Identify protocol execution risks and employ mitigation strategies through the Risk Assessment and Categorization Tool (RACT).
Ensure clinical project team (CRAs/Central Monitors) is aware of scope, budget, and protocol obligations.
Escalate issues related to timeline, quality, and budget to project managers.
Lead and participate in key study meetings, providing strategic thinking and problem-solving.
Provide leadership and conflict resolution with site staff and principal investigators.
Coordinate with other functional teams to ensure study milestones (site activation, enrollment, and database lock) are met.
Maintain clinical study tools and templates, including Clinical Monitoring Plans, and ensure systems like CTMS are operational.
Provide training on protocol specifics, CRF completion, data plans, and SOPs.
Monitor study progress using clinical trial systems (CTMS, EDC, IVRS, etc.), ensuring timely execution.
Ensure quality and compliance in monitoring and site management deliverables.
Develop corrective action plans for study risks and ensure successful data cut and lock.
Qualifications:
Required:
Bachelor’s degree or RN in a related field, or equivalent education/experience.
Clinical trial experience in site management.
Understanding of risk-based monitoring, GCP, ICH guidelines, and applicable regulations.
Strong communication and problem-solving skills.
Proficiency in computer systems and project management tools.
Moderate travel required (approximately 20%).
Preferred:
Experience with clinical or central monitoring.
Knowledge of budget management and financial principles.
Why Syneos Health?
Syneos Health fosters a culture of growth and inclusivity, offering career development opportunities, peer recognition, and a supportive work environment. Join a global team dedicated to driving progress in clinical research and delivering therapies that change lives.
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