CTI Clinical Trial and Consulting Services

Auditor

• Review full computer system validation deliverables for regulated software, hardware, and laboratory instrumentation applications
• Conduct internal audits related to validated systems and IT processes
• Escalate unresolved observations to QA management
• Conduct vendor audits of SaaS vendors
• Prepare and distribute audit reports and assist with review of auditee response plans
• Assist QA leadership team with review of non-conformance root causes and implementation of effective corrective actions
• Maintain significant knowledge in global regulatory validation requirements
• Prepare training materials related to global validation requirements

Validation – IT Auditor II

Designer

• Translate all documented customer expectations in the CTI Laboratory Services database to provide seamless services
• Leverage technical, therapeutic area, client and CTI Laboratory Services process knowledge to provide a comprehensive review of the protocol
• Liaise with internal departments along with the Laboratory Project Manager to understand CTI Laboratory Services capabilities and assess the feasibility of requests to meet client needs related to study design
• Manage and solve technical changes, issues and concerns of high complexity work with little to no guidance
• Displays strong interpersonal and communication skills that will build strong internal relationships to ensure high quality study design
• Responsible for delivering quality technical services related to assigned clients. Ensure the consistent use of SOPs
• Performs quality self-review in addition to review for other Study Designers when requested
• Able to act efficiently in an environment with dynamic timelines and priorities
• Displays appropriate self-organization and ability to manage conflicting priorities
• Leads and participates in functional meetings and provides input, keeping processes up to date
• Act as a Technical Expert by participating in process improvement initiatives
• Other duties as assigned

Study Designer

Project Manager

• Overseeing and coordinating the operational aspects of safety/data monitoring committee projects ensuring quality, timeliness and client satisfaction.
• Manage all phases of additional client projects from planning to completion.
• Create timelines and project needs assessments.
• Organize resources to develop the project, including multifunctional project team, budget, external vendors, etc.; manage timelines.
• Produce or oversee timely production of quality deliverable, on budget.
• Identify challenges that arise and propose effective solutions.
• Oversight of final review and production of deliverables.
• Provide project status reports to client and management.
• Prioritize and manage resources to meet needs of several clients simultaneously.

Validation – IT Auditor II

Study Designer

Project Manager I, Regulatory & Scientific Affairs