Description
Syneos Health is seeking a Clinical Trial Manager II to work from home in Poland.
The Clinical Trial Manager II is responsible for managing clinical trials from Phase 1 to Phase 4, ensuring compliance with regulations, and delivering high-quality results.
Key responsibilities:
- Oversee site interactions, patient recruitment, and investigator payments
- Identify critical data and process risks, and develop mitigation strategies
- Review study scope, budget, and protocol content, and ensure team awareness of contractual obligations
- Use prior clinical experience and data to identify risks and propose solutions
- Escalate risks to project managers and provide status updates to clients and stakeholders
- Collaborate with functional leaders to coordinate delivery handoffs and meet study milestones
- Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan
- Provide training to study teams on protocol specifics, CRF completion, and Sponsor SOPs
- Oversee resourcing allocations, site assignments, and study team conduct
- Ensure quality of clinical monitoring, central monitoring, and site management deliverables
- Review project oversight dashboards and clinical trial systems to ensure data accuracy and timeliness
Requirements:
- Bachelor's degree or RN in a related field or equivalent experience
- Demonstrated ability to lead and align teams in achieving project milestones
- Experience working in an international environment
- Expertise in site management and monitoring (clinical or central)
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Strong conflict resolution and problem-solving skills
- Moderate travel may be required (approximately 20%)