Site Activation Manager

🕒 Agosto 20

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $86.000 - $170.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

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Worldwide Clinical Trials

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

Worldwide Clinical Trials é uma organização global de pesquisa clínica por contrato (CRO) que oferece serviços abrangentes de ensaios clínicos. A empresa é especializada em apoiar estudos em diversas áreas terapêuticas, como oncologia, cardiologia e doenças raras. Com mais de 30 anos de experiência, a Worldwide Clinical Trials enfatiza suporte personalizado e soluções sob medida ao longo de todo o ciclo de vida do desenvolvimento de medicamentos. Seus serviços incluem monitoramento clínico, gestão de dados, recrutamento de pacientes e consultoria regulatória, garantindo precisão e atenção personalizada para cada ensaio clínico.

Descrição

• Serve as the primary point of communication and accountability for study start-up and maintenance activities on assigned projects • Oversee functional groups involved in site activation to ensure critical path activities are completed on time and within budget • Compile, manage, track, and analyze site activation activities • Support feasibility and site identification activities as needed • Expedite the Site Qualification and Selection process • Communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM, and project team • Prepare risk assessment and mitigation plans for project deliverables • Ensure relevant study activities are included in the work order budget • Track out-of-scope activities and follow through on change orders • Develop and maintain site activation-related project plans • Contribute to SOPs, best-practice guidelines, training, and coaching • Provide input to departmental process improvement initiatives • Establish and interpret site activation metrics to drive corrective action • Contribute to proposals, budgets, and bid defense meetings • Report or escalate issues to appropriate Site Activation leadership • Comply with SOPs, ICH GCP, and applicable regulations • Liaise with functional contributors and vendors • Perform other duties as assigned

🎯 Requisitos

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science OR two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and experience within clinical research (e.g. CRA, Reg Affairs) • Minimum of 4 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience • Proficient in cross-cultural communication • Proficient in both spoken and written English • Understanding of regulatory processes and guidelines • Understanding of initiation, planning, and execution of clinical projects and overall project planning • Awareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations • Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude • Strong leadership and organizational management skills • Ability to exercise sound judgment, make decisions independently, and proactively identify and solve problems • Ability to motivate, lead and engage a team • Strong interpersonal, oral, and written communication skills • Demonstrated ability to collaborate across the business • Ability to handle multiple tasks in a fast-paced and constantly changing environment • Ability to work in an organized, methodical, and self-motivated manner

🏖️ Benefícios

• Competitive benefits package depending on location • Transparent compensation and pay equity