Study Manager – Ophthalmology

Vaga não está no LinkedIn

🕒 Maio 15

🌲 North Carolina – Remoto

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⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

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👻 Score fantasma 45%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Syneos Health

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

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements. • Acts as a primary liaison between the Company and the Customer. • Lead project team to ensure quality, timelines and budget management. • Accountable for the financial performance of each project. • Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. • Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. • Responsible for quality and completeness of TMF for assigned projects. • Responsible for study management components of inspection readiness for all aspects of the study conduct. • Prepare project management reports for clients and management. • Develop strong relationships with current clients to generate new and/or add-on business for the future.

🎯 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

• Health benefits to include Medical, Dental and Vision • 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) and sick time

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