Global Senior Project Specialist – Sponsor Dedicated

🕒 Agosto 19

🇩🇪 Alemanha – Remoto

⏰ Tempo Integral

🟠 Sênior

👻 Score fantasma 22%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Syneos Health

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

• Set up, maintain, and/or close out project files and study information, including regulatory documents, Trial Master File, enrollment, adverse events/serious adverse events, site supplies, institutional review board re-approvals, and data queries • Attend and participate in internal and external meetings, including sponsor, trusted process, functional, and investigator meetings • Prepare and distribute meeting minutes and action items • Follow up with team members on action items through closure • Maintain timely and effective communication among team members and site staff • Keep Project Leadership and Clinical Research Associates fully apprised of site and study status • Contact site staff as needed for critical information • Provide administrative support to Project Leads and functional leads • Ensure study documents are archived according to appropriate guidelines and policy • Support quality assurance activities, including audit and internal review preparation • Prepare documentation and follow through to resolution on actionable issues

🎯 Requisitos

• Associate’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing, or related field, or equivalent combination of education and experience • Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements • Previous experience as Project Specialist within a CRO/pharma company is essential • Strong organizational skills • Global trial experience • Ability to manage time and work independently • High proficiency with full MS Office Applications • Strong written and spoken communication, presentation, and interpersonal skills, with ability to inform, influence, convince, and persuade • Ability to travel if necessary preferred (approximately 5%) • High level of competence in English language

🏖️ Benefícios

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture • Diversity, inclusion, and belonging initiatives • Comprehensive resources including emerging technologies, data, science, and knowledge sharing

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