Principal IRT Project Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Manage initiatives aimed at developing, optimizing, and enhancing departmental processes, as well as associated systems/applications, training, and communication efforts.

• Serve as the Procedural Documentation Coordinator (PDC): oversee revisions of procedural documents (SOPs/WPDs); update internal procedural documentation (guidance documents, how-to guides, etc.); and lead compliance initiatives within the department.

• Assess training requirements and maintain an up-to-date departmental training matrix; create and/or approve training materials; facilitate training sessions.

• Guide staff in establishing new operational metrics (KPIs, KQIs, KRIs); evaluate operational metrics and provide actionable recommendations.

• Review and endorse communication strategies and materials, including team intranet sites.

• Collect information on potential or existing risks/issues and furnish detailed reports to management.

• Oversee all IRT quality events that may occur during the study.

• Guarantee that the study is consistently audit-ready.

• Participate in any study audits requiring IRT representation.

• Prepare, coordinate, and distribute meeting materials and communications according to timeline milestones.

⛳️ Requirements

• Bachelor's degree or an equivalent relevant formal academic/vocational qualification.

• Prior experience equivalent to 5+ years.

• Strong leadership, project management, and supervisory skills.

• Exceptional judgment, decision-making, escalation, and risk management capabilities.

• Expertise in process development and enhancement, particularly as it relates to clinical trials and clinical development.

• Investigative, analytical, and creative thinking abilities; keen attention to detail.

• Proficient negotiation skills.

• In-depth knowledge of IRT technology and its application.

• Strong computer proficiency.

• Familiarity with the practices, processes, and requirements of clinical trials.

• Understanding of procedural documentation.

• Ability to think across functions.

• Excellent interpersonal abilities.

• Strong oral and written communication skills, including proficiency in English, both spoken and written.

• Proven ability to lead and foster teamwork in a multi-disciplinary and/or multi-cultural environment.

• Knowledge of regulatory guidelines and directives.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Professional development opportunities.