Associate Director - IWRS Design and Development

Role Summary

The IWRS Design and Development Consultant leads the end-to-end implementation of Interactive Web Response System (IWRS), gathering requirements, coordinating execution, and ensuring compliance with clinical protocol requirements and regulatory standards. The role requires deep technical expertise in IWRS/IRT functionality to support complex study designs, advanced randomization, and robust data flow. Collaboration with medical teams, trial management, IT, data movement, and external partners is essential to deliver validated IWRS builds and maintain trial integrity.

Responsibilities

• Study Setup process management and oversight: partner with medical teams, internal partners, and third parties to enable clinical research; leverage inventory methodologies with Clinical Trial Study Management for optimal Supply Planning; influence trial design and protocol language for treatment assignment, dispensing, and data sets; provide back-up support for Global Support Help Desk; maintain GMP/GCP compliance; participate in inspections and audits; coordinate with Quality; manage complex working arrangements with CROs and multiple distribution networks; coordinate flow of information with multiple partners; resolve internet connectivity issues; mentor peers; foster integrated teamwork; drive system enhancements to IWRS.
• Consultation, study set-up and execution: build and maintain strong business partnerships; serve as technical expert for IWRS/IRT (randomization, dispensing, inventory methodologies); consult during protocol development and study build; assess patient management needs with Clinical Trial Project Managers; influence randomization methods with Statisticians; collaborate with Data Sciences to ensure IWRS data meets study needs; drive System Development Cycle including requirements gathering, study set-up, and FPV timelines; provide ongoing IWRS support and third-party IWRS consultation; ensure confidentiality and blinding.
• Process Improvement: identify opportunities for process optimization; participate in and support projects; implement countermeasures and lessons learned for crises.

Qualifications

• Required: Bachelors degree and 3 years' experience in clinical trials (or 7 years in related drug development areas); or high school diploma with 5 years' experience in clinical trials and/or 7 years in drug development; minimum of 2 years' experience developing and supporting IWRS/IRT studies.
• Preferred: deep understanding of clinical trial protocol designs and their relationship to IWRS development; proven ability to drive cross-functional process improvements; strong relationship-management and communication skills; project management capability; problem-solving skills for complex study designs; strong organizational and self-management skills; experience with third-party IVRS/IWRS systems; proficiency with IMPACT, CT-WIN, MS Office; fluent in English.

Skills

• IWRS/IRT technical expertise (randomization, dispensing, inventory methodologies)
• Cross-functional collaboration and stakeholder management
• Process optimization and project management
• Strong written and verbal communication in multi-cultural settings
• Problem-solving for complex study designs

Education

• Not specified beyond degree requirements in Qualifications

Additional Requirements

• Work outside core hours may be required; minimal travel may be required domestically and internationally