Clinical Trial Manager – Project Management

🕒 5 dias atrás

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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• Provide site management oversight, clinical monitoring and central monitoring deliverables focused on patient safety, protocol/GCP/regulatory compliance and data integrity • Oversee site interactions from post-activation through site closeout, including recruitment and investigator payments • Identify clinical trial management risks and develop or implement mitigations • Review scope of work, budget and protocol content; ensure the clinical project team understands contractual obligations and parameters • Escalate risks to timelines, quality and budget, and activities outside contracted scope • 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 • 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 the Clinical Monitoring Plan • Ensure CTMS, dashboards and other systems are configured and available, including overseeing UAT as needed • Coordinate initial and ongoing training for the study team • Oversee CRA and Central Monitor resourcing, site assignments and team conduct • Monitor quality, progress and compliance of clinical monitoring, central monitoring and site management deliverables • Review clinical trial systems and dashboards to oversee site and patient activities and timely operational execution • Review site and central monitoring documentation, request revisions and document approvals in CTMS • Interact with clients and functional departments regarding clinical monitoring and site management deliverables • Provide status updates on deliverables and risks to clients, project management and leadership • Provide solutions for protocol execution and site management obstacles • Support inspection readiness, corrective action plans, and data cut and lock deadlines • Assess study-specific process, training and monitoring-plan compliance and identify emerging risks • Provide performance feedback to line managers

🎯 Requisitos

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience • Demonstrated ability to lead and align teams toward project milestones • Capability to work in an international environment • Expertise in clinical site management and monitoring • Preferred experience with risk-based monitoring • Understanding of clinical trial management financial principles and budget management • Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements • Good computer skills • Good communication, presentation and interpersonal skills • Strong conflict resolution skills • Ability to apply problem-solving techniques to resolve complex issues and use a risk management approach • Critical thinking to determine causes and appropriate solutions • Moderate travel may be required, approximately 20%

🏖️ Benefícios

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Collaboration with colleagues from across the world • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Multiple career paths and employment opportunities • Reasonable accommodations, when appropriate