Project Manager – Sponsor Dedicated, Inflammation

🔥 19 horas atrás

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷‍♀️ Gerente de Projetos

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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 guidance and daily oversight for successful management of all aspects of international clinical trials within designated budgets and timelines • Communicate with functional peers regarding project status and issues and ensure project team goals are met • Oversee operational aspects and conduct of assigned clinical trials, including study start-up, enrollment, maintenance, and close-out • Prepare and/or contribute to study-related documents, including clinical protocols, informed consent forms, pharmacy manuals, monitoring plans, CRFs, CRF completion guidelines, study plans, and clinical study reports • Coordinate data review supporting interim/final data analysis • Participate in study strategy development • Maintain study timelines • Contribute to study budget development • Contribute to RFP development and participate in CRO/vendor selection • Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements • Manage CRO interactions and sponsor oversight of operational functional activities • Proactively identify study issues/risks and recommend or implement solutions • Organize and manage internal team, investigator, and other trial-specific meetings • Participate in recruiting and hiring CPA/CTMAs and support their professional development • Coach work-team members and ensure adherence to established guidelines

🎯 Requisitos

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology • Extensive Study Start-up Experience • Global clinical trial experience • Prior involvement in Inflammation studies • Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management • Highly developed leadership skills to successfully lead a clinical study team • Ability to deal with time demands, incomplete information or unexpected events • Must display strong analytical and problem solving skills • Attention to detail • Outstanding organizational skills with the ability to multi-task and prioritize • Excellent interpersonal, verbal and written communication skills are essential • Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities • Equivalent experience, skills, and/or education will also be considered

🏖️ 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) and sick time • company car or car allowance may be included