Start-up Team Manager

Vermutlich ein Geisterjob

🕒 vor 4 Monaten

🌲 North Carolina – Remote

infoinfo

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👔 Manager

🗣️🇺🇸🇬🇧 Englisch erforderlich

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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

• Lead site activation and manage complex site operations • Ensure compliance with regulatory standards • Support site recruitment and training efforts • Facilitate collaboration between trial sites and internal teams • Manage delivery of site activation within assigned regions • Oversee site activation according to timelines and quality standards • Coordinate SSU specialists across regions • Track critical-path site activation plans • Escalate regulatory and vendor setup issues • Facilitate knowledge transfer across countries within regions • Coordinate with Regional/Oversight Leads to resolve issues • Oversee EC submission strategy and required documents • Perform quality checks for central and local EC submission packages • Manage feasibility, site selection, contracts coordination, and EC/RA submissions • Ensure operational readiness, including site binders, ancillary supplies, lab kits, training, and system access • Monitor regional study status, identify risks, and provide metrics to the SSU Oversight Lead • Maintain regional startup metrics and tracking tools • Perform risk identification and contingency planning • Participate in risk escalation meetings and implement solutions • Manage country and site ICF timelines; review and approve country ICFs • Provide performance feedback to the People Manager and support staff learning opportunities • Prepare for and participate in country-level meetings • Oversee clinical trial insurance local policy country setup • Oversee and manage amendment implementation

🎯 Anforderungen

• Bachelor's Degree • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • SSU experience in CRO or Pharma organizations highly preferred • Equivalency of appropriate education, training and/or directly related experience may be considered • Effective collaboration with cross-functional teams • Knowledge of cross-functional project management principles • Strong organizational and multitasking skills • Attention to detail • Ability to identify and mitigate risks related to contractual deliverables • Cross-cultural awareness and adaptability • Comprehensive understanding of clinical research and development, medical and therapeutic areas, phases, and terminology • Ability to lead, liaise, and coordinate cross-functional project teams • Knowledge of clinical development guidelines and directives • Ability to work in an upright and/or stationary position for 6-8 hours per day • Ability to perform repetitive hand movements • Frequent mobility required • Ability to lift and carry 15-20 lbs • Ability to use a variety of computer software • Ability to communicate and understand spoken information • Ability to perform under stress and multitask • Regular and consistent attendance

🏖️ Vorteile

• Global team environment • Collaboration and development opportunities • Commitment to scientific excellence

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