Associate Director - IWRS Design and Development

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

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 strong collaboration with other business partners and external collaborators to ensure successful IWRS execution and compliance with regulatory requirements.

This position requires deep technical knowledge of IWRS/IRT functionality and capabilities. Individuals in this role must be capable of using this expertise to enable very complex study designs driven by advanced randomization schemes, complex sourcing strategies, automated inventory methodologies, and data flow requirements.

• Partner with medical teams, key internal business partners, and third parties to enable clinical research
• Leverage robust knowledge of multiple inventory methodologies to collaborate with Clinical Trial Study Management and facilitate optimal Supply Planning.
• Be an active and engaged member of the global trial development team influencing trial design and protocol language for all aspects of treatment assignment, dispensing, and associated data sets.
• Provide back‑up support for Global Support Help Desk, if required, and respond to customers in a timely manner; act as primary resource for Help Desk personnel for study set‑up and support questions.
• Maintain GMP/GCP compliance by following procedures applicable to clinical trial execution.
• Actively participate in external inspections and internal audits for responsible compounds and trials. Coordinate with Quality to ensure all preparation is complete and reviewed prior to inspection/audit start.
• Successfully operate in, and provide solutions to, complex working arrangements (CROs for particular functions; multiple distribution networks; etc.)
• Coordinate the flow of information with multiple partners (Medical, Stats, IT, Data Movement, Product Delivery, etc.)
• Manage the resolution of internet connectivity issues, which includes but is not limited to: working with clinical trial sites and CROs, collaborating with IT, providing status updates/resolution to study teams.
• Mentor and coach peers to enable their ability to support studies of increasing complexity
• Foster an environment of integrated teamwork and partnership via shared learning, accountability, influencing others without authority.
• Drive innovation by identifying and proposing system enhancements to the IWRS to enable productivity gains and support the growing complexities of the portfolio.

• Build and maintain strong business partnerships with teams, functions and affiliates.
• Serve as technical expert for all aspects of IWRS/IRT (e.g., randomization (including adaptive and advanced randomization), dispensing, inventory methodologies, etc.)
• Consult with and influence multiple functions during protocol development and the study build process, ensuring the IWRS study build supports the required capabilities while protecting the overall integrity of the study.
  • Cl…