Clinical Trial Manager II

🔥 0 minutes ago

🌐 Romania, Hungary – Remote

🇷🇴 Romania – Remote 🇭🇺 Hungary – 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

• Manage all aspects of the development, coordination, and implementation of Phase 1 through Phase 4 clinical research studies • Collaborate with principal investigators, research subjects, client teams, investigators, and clinic operations teams • Plan study logistics and resource usage • Track study progress against project milestones, client deliverables, and budget • Ensure compliance with applicable regulations, protocol, GCP, and patient safety and data integrity requirements • Oversee site interactions from activation through closeout, including recruitment and investigator payments • Identify clinical data, process, protocol execution risks, and risk mitigations • Review scope of work, budget, protocol content, and contractual obligations • Escalate risks to timelines, quality, budget, and out-of-scope activities • Participate in and present at key meetings, including Kick Off Meetings • Coordinate handoffs with Study Start Up, Patient Recruitment, Data Management, and other functional leaders • 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 initial and ongoing study team training • Oversee CRA and Central Monitor resourcing, site assignments, conduct, and delivery risks • Review monitoring documentation, dashboards, and clinical trial systems • 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

🎯 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 among project team and with sites • 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 when identifying 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 • Total rewards program • Inclusive culture • Reasonable accommodations, when appropriate, to assist employees or applicants with disabilities