Clinical Team Manager – Senior

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🕒 vor 10 Tagen

🌐 Vereinigte Staaten, Kanada – Remote

🇺🇸 Vereinigte Staaten – Remote 🇨🇦 Kanada – Remote

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Vollzeit

🟠 Senior

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Thermo Fisher Scientific

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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

• Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. • Interprets data on complex issues and makes good business decisions with support from line management. • Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. • Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. • Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. • Manages all aspects of monitoring operations and quality for assigned studies, ensuring compliance with ICH GCP and applicable local regulations. • Develops clinical tools and study plans, collaborates with Biogen CSO (to include but not limited to CCSLs) and leads team meetings to maintain timelines, resources, and quality. • Serves as clinical subject matter expert for protocol and point of escalation for site manager as applicable. • Ensures timely deliverables, monitors trials, communicates with study sites, coordinates start-up activities, addresses regulatory requirements and provides input on forecast estimates and resource management. • Completes trip report reviews in compliance with study plan timeline. • Issue escalation per plan, responsible for identifying and reporting site performance issues, trend analysis. • May perform accompanied site visits with site manager and may attend meetings with Sponsor to discuss, but not limited to country/region start up progress, trending and issue identification/escalation, and general site/country updates. • Generate monitoring plan and trip report completion annotations.

🎯 Anforderungen

• Bachelor's degree • Previous experience comparable to 5+ years • Monitoring or Study Management, and Oversight experience preferred • Extensive Neuroscience experience preferred • Prior client-dedicated experience preferred • Advanced mentoring/leadership/supervisory skills • Excellent clinical trials monitoring skills; ideally remote AND onsite experience • Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines) • Strong organizational and negotiation skills • Strong attention to detail • Advanced written and oral communication skills • Strong knowledge of English language and grammar • Demonstrated use of computer to include data entry, archival and retrieval • Ability to travel as needed • Excellent team player with team building skills • Excellent interpersonal and conflict resolution skills • Advanced ability to utilize problem-solving techniques applicable to constantly changing environment • Solid knowledge of medical/therapeutic areas and medical terminology

🏖️ Vorteile

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Range of employee benefits