Principal IRT Project Manager

Job not on LinkedIn

🔥 20 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

👷‍♀️ Project Manager

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Oversee initiatives to develop, optimize and improve departmental processes, associated systems/applications, training and communications • Fulfill role of PDC (Procedural Documentation Coordinator): manage revisions of PPD procedural documents (SOPs/WPDs); update internal procedural documents (guidance docs, how-to guides, etc.); lead compliance efforts within the department • Identify training needs and maintain current departmental training matrix; develop and/or approve training materials; lead training sessions • Lead staff in defining new operational metrics (KPIs, KQIs, KRIs); analyze operational metrics and prepare recommendations • Review and approve communication methods and materials, including the team intranet sites • Gather information regarding potential or actual risks/issues and provide detailed information to management • Manage all IRT quality events that may arise for the study • Ensure the study is always audit ready • Attend and participate in any study audit that requires IRT attendance • Prepare, coordinate, and deliver meeting materials and communications per timeline milestones

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 5+ years • Effective leadership, project management, and management skills • Excellent judgment, decision making, escalation and risk management skills • Mastery in process development and improvement, especially as it applies to clinical trials and clinical development • Investigative, analytical and creative thinking skills; strong attention to detail • Strong negotiation skills • Expert knowledge of IRT technology and system use • Strong computer skills • Knowledge of the practices, processes and requirements of clinical trials • Knowledge of procedural documents • Ability to think cross-functionally • Excellent interpersonal skills • Effective oral and written communication skills including the ability to communicate in English, both orally and in writing • Demonstrated ability to direct and promote teamwork in a multi-disciplinary and/or multi-cultural team setting • Knowledge of regulatory guidelines and directives

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexibility work arrangements • Professional development opportunities