Associate Director – Project Management

🕒 6 dias atrás

🏖️ New Jersey – Remoto

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💵 $150.000 - $200.000 / ano

⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

🦅 Patrocina Visto H1B

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Everest Clinical Research

Everest Clinical Research

501 - 1000 funcionários

Fundada em 2004

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Everest Clinical Research é uma organização de pesquisa por contrato (CRO) global que fornece serviços completos de ensaios clínicos e expertise em biometria para patrocinadores das indústrias farmacêutica e biotecnológica. A empresa oferece operações clínicas e gestão de projetos, gestão de qualidade baseada em risco e monitoramento centralizado, monitoramento médico, farmacovigilância, gestão de dados clínicos, bioestatística e programação estatística, estratégia regulatória e submissões, além de soluções tecnológicas como IRT/RTSM e ePRO/eCOA. A Everest se posiciona como um parceiro de alta qualidade, com alcance global e expertise terapêutica em oncologia, neurologia, doenças respiratórias, doenças raras e imunologia.

Descrição

• Oversee project planning, communication, and execution of clinical research and development services • Train, manage, and oversee Project Managers, including performance assessments • Review Project Manager applicants and recommend hires in consultation with the President • Develop, update, and review governing documents, policies, and SOPs • Plan and implement new client service delivery requests and support existing client portfolios • Facilitate project planning, task and deliverable identification, and resource assessment across functional areas • Track project progress using strategic planning and project tracking methods and tools • Provide monthly project progress status reports • Conduct project progress status meetings and escalate planning, resource, performance, and external risks • Ensure smooth project startup, continuation, and completion with functional area directors and managers • Interact with clients regarding resource requirements and project management • Manage projects involving data management, statistics, medical writing, IWRS, monitoring and adjudication committees, and regulatory submissions • Define work scopes and estimate budgets; develop and manage cross-functional work plans, resources, budgets, quality deliverables, and timelines • Manage Phase I–IV clinical trials according to ICH, FDA, Health Canada, EMA, and other applicable requirements • Lead cross-functional project teams and coordinate activities with sponsors, supporting groups, and vendors • Track financial status, expenses, project tasks, timelines, hours, and budgets; alert management to major deviation risks • Prepare and present project status reports to internal and external stakeholders • Facilitate meetings, problem-solving, conflict resolution, action items, and key-decision communication • Conduct lessons-learned meetings and contribute to staff performance evaluations • Assist with RFIs, RFPs, work scopes, budgets, and contract administration when required • Perform clinical trial planning, management, and site monitoring from initiation through closure when required

🎯 Requisitos

• B.Sc. or M.Sc. in life sciences or health related field • 12+ years’ experience in clinical research and development within a pharmaceutical, biotechnology or CRO setting • Line management experience required • Demonstrated ability to lead and develop others within functional area • Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing • Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations • Ability to define scopes and estimate budgets, and plan and manage projects including resource requirements, utilization, hours spent versus budgets, key deliverables, and timelines • Demonstrated leadership abilities, including setting goals and driving achievement within allocated resources, timelines, and budgets • Excellent interpersonal, oral, and written communication skills • Demonstrated strong negotiation and presentation skills • Strong problem-solving ability, including conflict resolution • Experience as a clinical trial monitor, initiating, monitoring, and closing out clinical trials desirable

🏖️ Benefícios

• Medical, dental, and vision coverage • Life and AD&D insurance • Short- and long-term disability • Tuition reimbursement • Fitness reimbursement • Employee assistance program (EAP) • 401(k) retirement plan • Generous paid time off and sick leave • Opportunity to earn a performance-based bonus • Recruitment and selection process accommodations for candidates with disabilities

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