Study Manager – Infectious Disease

🕒 Outubro 13

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

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• Aberta há 29 dias.
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• Sem salário divulgado.

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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

• Manage interdisciplinary clinical research studies as a project manager • Ensure compliance with GCP, relevant SOPs, and regulatory requirements • Act as primary liaison between the Company and the Customer • Ensure timely study launch, conduct, and closeout • Lead project teams to ensure quality, timelines, and budget management • Manage project financial performance • Coordinate study conduct partners and manage issues • Oversee project deliverables and TMF quality and completeness • Maintain study information in databases and systems • Manage inspection readiness and project plans • Plan, coordinate, and present internal and external meetings • Prepare project management reports for clients and management • Develop contingency plans and risk mitigation strategies • Develop client relationships to generate future business • Participate in bid defense meetings as a potential project manager • May line manage project management team members and clinical monitoring staff

🎯 Requisitos

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience • Clinical research organization (CRO) and relevant therapeutic experience preferred • Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements • Strong organizational skills • Strong ability to manage time and work independently • Direct therapeutic area expertise • Ability to embrace new technologies • Excellent communication, presentation, interpersonal skills, both written and spoken • Ability to travel as necessary (approximately 25%)

🏖️ Benefícios

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • 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 • Company car or car allowance may be included

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