Project Lead – Project Manager

Emploi pas sur LinkedIn

🕒 il y a 17 jours

🌲 North Carolina – Distant

🌲 North Carolina – Remote

⏰ Temps Plein

🟠 Senior

👷‍♀️ Chef de Projet

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Thermo Fisher Scientific

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1956

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific est le leader mondial dans le service aux sciences, avec un chiffre d'affaires annuel de plus de 40 milliards de dollars. Leur mission est de permettre à leurs clients de rendre le monde plus sain, plus propre et plus sûr en soutenant la recherche en sciences de la vie, en résolvant des défis analytiques complexes, en augmentant la productivité des laboratoires et en améliorant la santé des patients grâce aux diagnostics et au développement de thérapies révolutionnaires. Avec une équipe mondiale, ils offrent des technologies innovantes et des services pharmaceutiques à travers des marques telles que Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon et PPD.

Description

• Serve as the Project Lead and primary sponsor contact. • Accountable for overall delivery of the project (quality, time, cost). • Establish and communicate customer expectations to the project team. • Lead cross-functional project team to meet or exceed deliverables. • Ensure compliance with organization policies, SOPs, ICH-GCP. • Responsible for vendor management and financial stewardship at a trial level. • Drive Risk Identification and Issue Resolution at project level. • Manage out-of-scope activity and negotiate contracts.

🎯 Exigences

• B.A. or B. Sc. in a scientific discipline. • 6 + years in clinical operations management, managing clinical trials per quality, timeline, and budget expectations, preferably with a Sponsor company and a CRO. • Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skills. • Extensive knowledge of clinical development related to one or more trial phases (I, II, III), as well as cross-functional drug development. • Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development. • Ability to establish and execute operational plans. • Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems. • Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment. • Effective oral and written communication and presentation skills. • Proactive, solutions oriented and adaptable to changing priorities and situations.

🏖️ Avantages

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities