Senior Project Manager

🕒 Outubro 8

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $147.300 - $220.900 / ano

⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

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Precision Medicine Group

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2012

💼 Consultoria

🏥 Saúde

📦 Logística

💰 $35.200.000 Venture Round em 2021-03

Consulting • Healthcare • Logistics

A Precision Medicine Group é uma equipe global de especialistas dedicada à medicina de precisão, que combina ciências laboratoriais avançadas, informática translacional, assuntos regulatórios, insights de pagadores e comunicações de marketing. A empresa foca em superar desafios de desenvolvimento de produtos e de comercialização para clientes dos setores farmacêutico e de ciências da vida. Seus serviços incluem P&D orientada por biomarcadores, bem como suporte à comercialização para organizações de ciências da vida, do lançamento à maturidade do produto. A Precision Medicine Group opera por meio de duas frentes principais: Precision for Medicine e Precision AQ, especializadas em soluções clínicas e comerciais, respectivamente.

Descrição

• Plan, direct, coordinate and deliver activities for designated clinical study projects to meet quality, scope, cost and time objectives • Serve as primary point of contact and escalation point for clients • Coordinate and oversee functional services and external vendors against timelines and budgets • Manage study budgets, scope, out-of-scope activities, financial health, profitability, billable hours, billing and forecasting • Collaborate with clinical operations and functional teams in study delivery and clinical activities • Develop comprehensive project plans, timelines and proactive risk mitigation strategies • Ensure project quality, eTMF inspection readiness, quality notifications and corrective/preventive action plans • Establish tracking metrics for trial and team progress • Prepare project status updates and report KPIs and progress to clients and senior management • Lead internal and client meetings and set project-team expectations • Communicate protocol and study issues, deviations and required actions • Conduct formal presentations, including bid defenses • Implement and monitor study-specific training compliance • Support business development and marketing activities, including travel to bid-defense meetings • Provide ongoing feedback and annual performance reviews for functional team members • Complete assigned duties, organizational training, time reporting and administrative requirements

🎯 Requisitos

• North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred • EU: Degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred • Minimum of 7 years of clinical research experience or proven competencies for this position • Minimum of 4 years of direct project management experience • Experience managing complex and global trials • Ability to travel domestically and internationally, including overnight stays • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC and CTMS • Proven communication and interpersonal skills to effectively interface with others in a team setting • Proven organizational skills, attention to detail, and a customer service demeanor • Knowledge of ICH-GCP and relevant Precision SOPs, with ability to implement them • Direct work experience in a global, cross-functional project management environment • Good understanding of cross-functional management • Good understanding of project planning, risk management and change management with awareness of appropriate escalation • Proven experience in strategic planning, risk management and change management • High level of integrity and professional and ethical standards • Ability to lead and inspire excellence within a study team • Proven time management, negotiation, critical thinking, decision-making, analytical and interpersonal skills • Proven presentation, verbal and written communication skills • Good understanding of project management software • In-depth proven experience in pharmaceutical and/or device research required • Experience with oncology and cell and/or gene therapy preferred • Must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefícios

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation