Associate Director - IWRS Design and Development

Role Summary

The IWRS Design and Development Consultant is responsible for all aspects of Interactive Web Response System (IWRS) implementation, including gathering system requirements from customers; coordinating and planning the execution; and ensuring the IWRS is designed and functions according to clinical protocol requirements and customer specifications. This position requires deep technical knowledge of IWRS/IRT functionality and capabilities, and collaboration with multiple partners to ensure regulatory compliance and successful IWRS execution. The role supports complex study designs driven by advanced randomization schemes, sourcing strategies, and data flow requirements.

Responsibilities

• Study Setup process management and oversight: Partner with medical teams and third parties to enable clinical research; collaborate on supply planning; influence trial design and protocol language; support Help Desk and ensure GMP/GCP compliance; participate in inspections and audits; manage complex working arrangements and information flow; address network/connectivity issues; mentor peers; foster integrated teamwork; drive IWRS enhancements for productivity gains.
• Consultation, study set-up and execution: Build and maintain partnerships; serve as technical expert for IWRS/IRT (randomization, dispensing, inventory methods); influence protocol development and study build; assess patient management needs and implement IWRS solutions; coordinate with trial managers, statisticians, and data sciences; drive System Development Cycle (requirements, setup, timelines).
• Provide ongoing IWRS support and maintenance for Lilly trials; advise on third-party IWRS usage; ensure confidentiality and blinding as required.
• Process Improvement: Identify opportunities for process optimization; support corporate projects and initiatives; proactively address crises by identifying root causes and communicating countermeasures.

Qualifications

• Required: Bachelor’s degree and 3 years' experience in clinical trials (CDO, Product Delivery, etc.) and/or 7 years' experience in drug development, or high school diploma with 5 years' clinical trials and/or 7 years' drug development experience; minimum of 2 years prior experience developing and supporting IWRS/IRT studies.
• Preferred: Deep understanding of clinical trial protocol designs and IWRS development; proven ability to drive process improvements across teams; strong relationship-building and communication with leadership; project management experience; problem-solving for complex study designs; strong organizational and self-management skills; cross-functional collaboration with global partners and vendors; fluency in English; prior experience with third-party IVRS/IWRS; proficiency with IMPACT, CT-WIN, MS Office; exemplary teamwork and interpersonal skills.

Education

• Not specified beyond the above qualifications; see Basic Qualifications for details.

Additional Requirements

• Work outside of core hours may be required to support the portfolio across the globe
• Minimal travel may be required, both domestic and international