Principal IRT Project Manager

Thermo Fisher Scientific is a global team that values passion, innovation, and a commitment to scientific excellence. The Principal IRT Project Manager will lead the strategic direction, planning, and execution of Interactive Response Technology (IRT) projects, ensuring their success in pivotal clinical trials.

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
• Previous experience that provides the knowledge, skills, and abilities to perform the job (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