Clinical Trial Manager II

🔥 6 minutes ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Provide site management oversight, clinical monitoring and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity • Oversee site interactions from post-activation through site closeout, including patient recruitment and investigator payments • Identify critical data, process and protocol-execution risks and develop risk mitigations • Review study scope of work, budget and protocol content; ensure clinical project teams understand contractual obligations • Identify and escalate risks affecting timelines, quality and budget, including out-of-scope activities • Participate in and present at key meetings, including Kick-Off Meetings • Serve as an escalation point for investigator site staff and interact with principal investigators and site staff by phone or in person • Collaborate with Study Start Up, Patient Recruitment, Data Management and other functional leaders to meet study milestones • Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans • Ensure CTMS, dashboards and other systems are configured and available, including user acceptance testing and access/audit-trail reviews • Coordinate study-team training on protocols, CRF completion, dashboards, SOPs, clinical plans, data plans and timelines • Oversee CRA and Central Monitor resourcing, site assignments, conduct and delivery risks • Ensure quality and visibility of clinical monitoring, central monitoring and site-management deliverables using approved systems and tracking tools • Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS and central-monitoring dashboards • Ensure assigned team members understand and comply with monitoring strategies, CMP/SMP and risk plans • Review site and central monitoring documentation and ensure revisions, approvals and deliverables meet company and sponsor specifications • Provide client, project-management and leadership updates on clinical deliverables and risks • Provide solutions for protocol-execution and site-management obstacles • Support inspection readiness for clinical trial management scope • Oversee CRAs and Central Monitors, assess process and training compliance, identify emerging risks and support corrective action plans • Support activities to achieve data-cut and database-lock deadlines • Provide line managers with staff-performance feedback • May be assigned to larger, more complex trials

🎯 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 use a risk-management approach • Critical-thinking ability to identify issues, determine causes and select appropriate solutions • 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 and supportive work environment

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