Senior Project Manager

🕒 Outubro 8

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $147.300 - $220.900 / ano

⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

👻 Score fantasma 0%

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Precision For Medicine

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $75.000.000 Private Equity Round em 2015-12

Healthcare • Consulting • Logistics

A Precision For Medicine é uma organização líder especializada em apoiar o desenvolvimento e a comercialização de terapias inovadoras, particularmente em oncologia, doenças raras e condições autoimunes. Com uma gama abrangente de serviços, incluindo gestão de ensaios clínicos, serviços de laboratório e coleta de biospecimens, eles integram capacidades avançadas de biomarcadores e soluções de manufatura para simplificar os complexos processos de desenvolvimento clínico. Sua missão é acelerar a pesquisa e trazer soluções médicas que mudem a vida dos pacientes, superando as ineficiências tradicionais geralmente encontradas no cenário de desenvolvimento farmacêutico.

Descrição

• Plan, direct, coordinate, and deliver activities for designated clinical study projects to achieve quality, scope, cost, and time objectives • Serve as primary point-of-contact and escalation point to the client • Coordinate and oversee functional services and external vendors according to established timelines and budgets • Manage study budgets, scope, out-of-scope activities, change orders, and project financial health • Collaborate with clinical operations and functional teams in study delivery and clinical activities • Develop comprehensive project plans, timelines, risk management, and mitigation strategies • Ensure quality management, eTMF inspection readiness, quality notifications, and corrective/preventive action plans • Establish tracking metrics for trial and team progress • Prepare project status updates and report progress, KPIs, solutions, and opportunities to clients and senior management • Lead internal and client meetings and set expectations for project teams • Communicate protocol/study issues and deviations and implement necessary 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 • Perform other duties assigned by management • Remain compliant with organizational training, time-reporting, and administrative requirements • Provide ongoing feedback and annual performance reviews for functional team members

🎯 Requisitos

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field (North America) • Degree or equivalent combination of education/experience in science or health-related field (EU) • 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 in 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 • Demonstrates knowledge of ICH-GCP and relevant Precision SOPs, as well as the ability to implement such items • 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 an 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 • Ability to create an environment where study team members have a sense of ownership • Results oriented, accountable, motivated and flexible • Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills • Proven presentation, verbal and written communications skills • Good understanding of project management software • In depth proven experience in pharmaceutical and/or device research required • Experience with oncology & cell and/or gene therapy preferred • Candidates 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