Senior Project Manager

🕒 vor 11 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $147.300 - $220.900 / Jahr

⏰ Vollzeit

🟠 Senior

👷‍♀️ Projektmanager

🗣️🇺🇸🇬🇧 Englisch erforderlich

Jetzt Bewerben
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Logo of Precision For Medicine

Precision For Medicine

1001 - 5000 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

💰 €75.000.000 Private Equity Round im 2015-12

Healthcare • Consulting • Logistics

Precision for Medicine ist eine führende Organisation, die sich auf die Unterstützung der Entwicklung und Kommerzialisierung innovativer Therapien spezialisiert hat, insbesondere in der Onkologie, bei seltenen Erkrankungen und Autoimmunerkrankungen. Mit einem umfassenden Spektrum an Leistungen, darunter das Management klinischer Studien, Labordienstleistungen und die Gewinnung von Bioproben, integriert das Unternehmen fortschrittliche Biomarker-Kompetenzen und Herstellungslösungen, um die komplexen Prozesse der klinischen Entwicklung zu straffen. Ihre Mission ist es, die Forschung zu beschleunigen und Patientinnen und Patienten lebensverändernde medizinische Lösungen bereitzustellen, indem traditionelle Ineffizienzen überwunden werden, wie sie im Umfeld der pharmazeutischen Entwicklung typischerweise auftreten.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

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

Jetzt Bewerben

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