Project Manager, eCOA Manager

🕒 Setembro 18

🇦🇷 Argentina – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷‍♀️ Gerente de Projetos

👻 Score fantasma 10%

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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 customer-focused management of Clinical Surveillance & Training (CST) scoped services to support scientific integrity and data quality in clinical trials • Liaise with customers, vendors, and investigative sites from project start-up through final customer deliverables • Represent the CST team on small to large-sized studies or programs • Interact with functional groups, vendors, license holders, Key Opinion Leaders, and Sponsors • Serve as Project Lead in CST stand-alone projects and Functional Lead in full-scope or multiple-protocol projects • Manage CST deliverables for scoped-service vendors, scale license holders, and/or KOLs • Manage license procurement, scale translation requirements, and paper scale worksheet development • Manage CST service-related documentation and templates, including development and testing of the Study Training and Engagement Portal • Ensure quality, timely delivery, and implementation of CST services • Develop and maintain study-specific CST plans in accordance with SOPs and Work Instructions • Contribute to functional project plans • Provide status updates to internal and Sponsor project teams, including delivery risks and timeline delays • Serve as the central point of contact for CST-related project issues • Create and maintain CST metric reports for client delivery • Attend internal and Sponsor meetings as the lead CST representative • Maintain project documentation and ensure complete and accurate filing in the Trial Master File • Identify risks and develop mitigation plans • Participate in Sponsor, internal, or agency audits and inspections • Manage CST scope, out-of-scope activities, overburn, revenue recognition when delegated, invoice management, and/or KOL contracts and management • Plan, manage, and request CST resources and provide resource updates • Train and mentor internal team members

🎯 Requisitos

• Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred • Prior experience in study coordination, contract research organization (CRO), pharmaceutical, biotechnology or rater training vendor company preferred • Excellent written and spoken communication, presentation, and interpersonal skills • Good organizational, planning, customer service, and time management skills • Ability to multitask under tight deadlines while providing attention to detail • Ability to manage time and work independently • High level of competency in English language • Proficiency with MS Office Applications • Strong knowledge of Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable regulatory requirements • Ability to travel as necessary, up to 25%

🏖️ Benefícios

• 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