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Associate Manager / Manager - IRT Systems

We are seeking an experienced IRT Systems consultant who will be responsible for managing our client's Clinical IRT Systems as an expert resource in supply for multiple global clinical trials and the Systems Analyst, collaborating with Clinical Operations, Information Technologies and Quality Systems in the selection, implementation and maintenance of IRT systems. This role is responsible for hands-on management of setting up the IRT systems and daily/routine IRT management. This position will report to the Associate Director, Clinical Supply Chain. 

Essential Areas of Responsibility:

• Collaborate with Clinical Supply and Clinical Operations to understand study design, dosing and initial and resupply clinical supply requirements
• Lead URS and UAT set-up in conjunction with IRT Vendor, Clinical Supply and Clinical Operations
• Work with IRT Vendor, Biostats, Clinical Operations and/or CRO to obtain randomization input into system if applicable and or unit serialization for open-label studies
• Maintain IRT day to day operations, including but not limited to depot setup, supply strategies, country and lot input/releases, manual shipments, expiry date management, and inventory levels
• Maintain blind of the clinical supplies
• Troubleshoot IRT issues and provide timely resolution during the conduct of the clinical studies.
• Manage IRT vendors
• Set up vendor scorecard and help establish KPIs
• Assist in Forecast / Demand Planning
• Manage drug supply maintenance alerting clinical supplies the need for resupply based on enrollment and inventory at depots.
• Provide depot inventories to Clinical Supplies and Forecast Planner as applicable.
• Perform additional tasks/responsibilities as applicable. 

Requirements:

AD/BA in Scientific or related field or equivalent with 5+ years of IRT management experience including systems such as EDC and eTMF experience.  Working knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices as well as Microsoft Office, Word, Excel and PowerPoint required. Prior experience working with multiple Clinical Information Systems simultaneously along with general knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines.

Qualifications:

• High attention to detail and demonstrated ability to manage multiple critical path projects concurrently
• Demonstrates flexibility through adapting to external environment influences through development of new strategies and tactics
• Excellent communication and influencing skills, strong collaboration skills

• Good organization and project management skills with a demonstrated ability to work independently, take initiative, complete tasks to deadlines.
• Ability to communicate effectively with external vendors, including issue escalation, and responding to inquiries and concerns
• Must be able to work in a fast-paced environment with demonstrated ability to prioritize multiple competing task