Study Manager – Respiratory

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🕒 Maio 15

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

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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

• 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 to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement • 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 • Accountable for all project deliverables for each project assigned • Responsible for quality and completeness of TMF for assigned projects • Accountable for maintenance of study information on a variety of databases and systems • Responsible for study management components of inspection readiness for all aspects of the study conduct • Oversight for development and implementation of project plans • Plan, coordinate and present at internal and external meetings • Prepare project management reports for clients and management • Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals • Develops strong relationships with current clients to generate new and/or add-on business for the future • May participate in bid defense meetings where presented as potential project manager • May be required to line manage other 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

• 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