Principal IRT Project Manager

Thermo Fisher Scientific

Principal IRT Project Manager overseeing Interactive Response Technology (IRT) projects for clinical trials. Driving process improvements and managing compliance within the department.

Posted 7/18/2026full-timeRemote • North Carolina • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in process development and improvement within clinical trials, alongside strong leadership and project management capabilities. Proficient in IRT technology and regulatory guidelines, with a focus on effective communication and teamwork in diverse settings.

Highest-signal resume keywords

Process Development and ImprovementIRT Technology ExpertiseLeadership and Project ManagementRegulatory Guidelines KnowledgeAnalytical and Investigative Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process DevelopmentOperational Metrics AnalysisTraining Material DevelopmentSOP ManagementRisk ManagementKPI DefinitionClinical Trial PracticesDocument Revision ManagementQuality Event ManagementAudit Readiness

Soft Skills

Effective LeadershipExcellent JudgmentStrong Negotiation SkillsInterpersonal SkillsCreative Thinking

Tools & Technologies

IRT SystemsCommunication ToolsTraining PlatformsDocument Management Systems

Industry Keywords

Clinical TrialsRegulatory GuidelinesProcedural DocumentsCompliance EffortsMulti-Disciplinary Teamwork

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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