Clinical Team Manager – Senior

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🕒 vor 4 Tagen

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Vollzeit

🟠 Senior

👔 Manager

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Thermo Fisher Scientific

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1956

🏥 Gesundheitswesen

📦 Logistik

🏭 Fertigung

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific ist der weltweite Marktführer im Dienste der Wissenschaft mit einem Jahresumsatz von mehr als 40 Milliarden US‑Dollar. Ihre Mission ist es, Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen – indem sie die lebenswissenschaftliche Forschung vorantreiben, komplexe analytische Herausforderungen lösen, die Produktivität in Laboren steigern und die Gesundheit von Patienten durch Diagnostik sowie die Entwicklung lebensverändernder Therapien verbessern. Mit einem globalen Team bietet das Unternehmen innovative Technologien und pharmazeutische Dienstleistungen über Marken wie Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon und PPD.

Beschreibung

• Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. • Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. • Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. • Collaborate with the clinical team and other departments as needed to meet deliverables of the project. • Responsible for the implementation and training of standardized clinical monitoring processes within the study. • Ensure achievement of the final clinical deliverable within the contractual time period specified. • Communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. • May coordinate all start-up activities, and ensure that essential document quality meets the expectation of Regulatory Compliance Review.

🎯 Anforderungen

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). • Preferred experience: experience in STM role and/or previous experience in non-interventional / Phase IV studies / RWE studies. • Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams. • Strong planning and organizational skills to enable effective prioritization of workload and workload of team members. • Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization. • Solid understanding of change management principles. • Comprehensive understanding of the practices, processes, and requirements of clinical monitoring. • Strong judgment, decision making, escalation, and risk management skills. • Effective oral and written communication skills, including English language proficiency. • Capable of evaluating own and team members workload against project budget and adjust resources accordingly. • Strong financial acumen and knowledge of budgeting, forecasting and fiscal management. • Strong attention to detail. • In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. • Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. • Capable of independently managing clinical only studies.

🏖️ Vorteile

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options