Principal IRT Project Manager

Thermo Fisher Scientific is a global leader in healthcare, and they are seeking a Principal IRT Project Manager to lead the strategic planning and execution of Interactive Response Technology (IRT) projects within clinical trials. This fully remote role involves managing departmental processes, overseeing compliance, developing training, and ensuring audit readiness, while collaborating cross-functionally and managing budgets.

Responsibilities:

• Oversee initiatives to develop, optimize and improve departmental processes, associated systems/applications, training and communications to include:
• Oversee process improvement initiative teams and/or represents team functions in cross-departmental initiatives; provide mentorship, guidance, support and training for staff and coach teams in developing and implementing process improvement initiatives
• Fulfill role of PDC (Procedural Documentation Coordinator): manage revisions of PPD procedural documents (SOPs/WPDs); updates internal procedural documents (guidance docs, how-to guides, etc.); lead compliance efforts within the department with departmental and PPD processes and associated systems/applications, training and communications; 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 prepares recommendations
• Review and approve communication methods and materials, including the team intranet sites (corporate Infront site and internal SharePoint site)
• Identify and collate information to support prioritization of systems-related business needs and processes and develops recommendations; make recommendations required to prioritize business process improvement needs through quality event CAPA actions, process and systems improvement and optimization, and metrics/trend analyses
• Review/approve audit report responses and ensure deliverables committed to are feasible and within a reasonable due date; provides visibility to management on upcoming/past-due audit deliverables
• Serve as the primary IRT contact for sponsors and study team members during the life of the study including understanding the IRT system requirements and functionality and managing the IRT Vendor in all tasks related to the study
• Partner with functional area leads to identify and evaluate fundamental issues on projects
• Gather information regarding potential or actual risks/issues and provide detailed information to management to ensure the risks/issues are surfaced and mitigated. 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
• Perform study specific informal testing, review study specific system support guidelines for accuracy and completeness. Manage the UAT testing phase with all appropriate parties
• Prepare, coordinate, and deliver meeting materials and communications per timeline milestones. Attend/facilitate meetings and communications with sponsors, vendors, and cross-functional team members
• Manage the IRT budget for the life of the study. Ensure accurate hours are included for various tasks. Review and approve all vendor invoices. Escalate any discrepancies or adjustments needed in the IRT budget

Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• At least 5 years' relevant experience
• Expertise in clinical trials
• Expertise in IRT technology
• Knowledge of regulatory guidelines
• Strong leadership skills
• Strong project management skills
• Strong communication skills
• Ability to work independently
• Ability to manage multiple tasks
• High standards of accuracy and attention to detail