Job Title:
Clinical Trial Manager I
Company:
Syneos Health
A global biopharmaceutical solutions organization specializing in accelerating customer success by providing integrated clinical, medical affairs, and commercial services.
Location:
Portugal (Europe)
Job ID:
25003425-PRT
Updated:
Today
Job Summary:
The Clinical Trial Manager I will oversee the clinical monitoring, site management, and risk mitigation for clinical trials. The role involves ensuring regulatory compliance, managing risks, and collaborating with cross-functional teams to ensure successful trial delivery, meeting key milestones and project goals.
Key Responsibilities:
Oversee site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol compliance, and data integrity.
Manage post-activation site interactions, including recruitment and investigator payments.
Identify and mitigate protocol execution risks using the Risk Assessment and Categorization Tool (RACT).
Review the study scope of work, budget, and protocol content to ensure alignment with clinical project team objectives.
Address risks related to clinical trial deliverables (timeline, quality, budget) and escalate issues as needed.
Lead key meetings, including Kick-Off, and provide solutions for obstacles in trial execution.
Collaborate with other functional leaders to meet study milestones like site activation, enrollment, and database lock.
Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan.
Provide training on protocol specifics, CRF completion, data plans, and SOPs to the study team.
Oversee clinical resources, including CRAs and Central Monitors, and ensure quality in deliverables.
Track progress using clinical trial systems (CTMS, EDC, IVRS, etc.) to monitor study execution and compliance.
Manage communication with investigators and other site staff, resolving issues as needed.
Ensure inspection readiness and support corrective action plans for study risks.
Qualifications:
Required:
Bachelor’s degree or RN in a related field or equivalent education/experience.
Experience in clinical trial site management.
Familiarity with risk-based monitoring, Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.
Strong communication, problem-solving, and conflict resolution skills.
Ability to apply critical thinking to resolve complex issues and manage study risks.
Good computer skills and proficiency in project management tools.
Moderate travel requirement (approximately 20%).
Preferred:
Experience with clinical or central monitoring and budget management.
Why Syneos Health?
Syneos Health offers a dynamic and inclusive work environment where employees can thrive through career development, recognition, and a supportive company culture. Join a global team that drives progress in clinical research.
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