eCOA Project Manager – North America, Argentina

🕒 Setembro 2

🌐 Estados Unidos, Canadá, +2 outros países – Remoto

🇺🇸 Estados Unidos – Remoto (EUA) 🇨🇦 Canadá – Remoto 🇲🇽 México – Remoto 🇦🇷 Argentina – Remoto

💵 $79.800 - $139.600 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷‍♀️ Gerente de Projetos

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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

• Lead eCOA activities from study startup through closeout • Manage study-specific eCOA project plans, timelines, milestones, and deliverables • Serve as the primary eCOA subject matter expert for assigned clinical studies • Ensure electronic assessments align with protocol requirements, study objectives, and regulatory expectations • Support global studies involving patient-reported outcomes, clinician-reported outcomes, and other electronic assessments • Drive implementation of lessons learned and continuous improvement best practices • Oversee eCOA software design, configuration, and deployment • Manage questionnaires, instruments, scales, assessments, visit schedules, device configurations, language requirements, and study workflows • Ensure systems are built, validated, and maintained accurately • Review and approve vendor deliverables • Coordinate system updates, enhancements, and maintenance • Develop UAT strategies and test scripts • Lead and execute UAT activities • Identify, document, and resolve testing issues • Drive inspection-ready documentation and testing records • Liaise between sponsors, internal teams, and eCOA vendors • Manage vendor timelines, deliverables, risks, and issue resolution • Provide project status updates and communicate key milestones • Participate in governance meetings and sponsor-facing discussions • Escalate risks proactively and drive solutions • Collaborate with Clinical Operations, Data Management, Biostatistics, Clinical Science, Assessment Science, Project Management, Technology Vendors, and Sponsors • Support study teams with eCOA processes, timelines, and best practices • Manage assessment licensing and copyright procurement • Coordinate with copyright holders and key opinion leaders • Oversee scale and instrument translations • Partner with translation vendors • Manage translation timelines, documentation, and vendor deliverables • Identify project risks and develop mitigation strategies • Monitor study health, timelines, and quality metrics • Ensure compliance with SOPs, work instructions, sponsor requirements, and industry regulations • Maintain project documentation and contribute to Trial Master File (TMF) readiness • Support audits, inspections, and quality initiatives • Manage competing priorities across multiple studies • Provide guidance and mentorship to project specialists and team members • Support resource planning and forecasting • Contribute to process improvement initiatives • Serve as a trusted consultant and problem solver for eCOA-related challenges

🎯 Requisitos

• Bachelor's degree or equivalent combination of education and relevant experience • Minimum of 4+ years of project management experience within eCOA, eClinical technologies, clinical trial technology vendors, CRO environments, or pharmaceutical or biotechnology organizations • Demonstrated experience leading end-to-end eCOA implementations across clinical studies • Experience managing software implementation projects and complex vendor relationships • Experience authoring and executing User Acceptance Testing (UAT) plans and scripts • Experience collaborating with cross-functional clinical research teams • Strong understanding of eCOA platforms and technologies • Strong understanding of patient-reported outcomes (PROs) • Strong understanding of clinical trial operations • Strong understanding of clinical study protocols • Strong understanding of data quality principles • Strong understanding of vendor oversight and governance • Strong understanding of risk management methodologies • Exceptional organizational, communication, and stakeholder management skills • Demonstrated ability to manage multiple studies and competing priorities simultaneously • Strong attention to detail with a quality-focused mindset • Ability to proactively identify problems and implement effective solutions

🏖️ Benefícios

• career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition and total rewards program • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time • Reasonable accommodations, when appropriate