Associate Director-IWRS Design and Development

Eli Lilly and Company • Indianapolis, IN

326d • $111,000 - $162,800

About The Position

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.

Requirements

• Bachelor’s degree
• Minimum of 5 years’ experience in clinical trials (CDO, Product Delivery, etc.) and/or 7 years’ experience in drug development in areas intersecting with clinical data management
• Minimum of 2 years prior experience developing and supporting studies in IWRS/IRT

Nice To Haves

• Deep understanding of various clinical trial protocol designs and their relationship to IWRS development
• Demonstrated effectiveness across teams and management levels to drive process improvements and influence decisions
• Ability to build productive relationships and effectively communicate with functional leadership
• Proven formal or informal project management capability
• Demonstrated problem-solving skills for complex study designs and issues
• Strong organizational and self-management skills
• Strong relationship-management skills including working across multi-disciplinary global business partners as well as external vendors
• Demonstrated strength in logical thought, problem solving ability and strategic thinking
• Strong written and verbal communication skills in multi-cultural settings
• Prior experience with third-party IVRS and/or IWRS systems
• Deep understanding and ability to utilize multiple computer applications (e.g. IMPACT, CT-WIN, MS Office)
• Exemplary teamwork/interpersonal skills
• Must speak fluent English

Responsibilities

• Study Setup process management and oversight
• 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
• 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
• Coordinate the flow of information with multiple partners
• Manage the resolution of internet connectivity issues
• Mentor and coach peers to enable their ability to support studies of increasing complexity
• Drive innovation by identifying and proposing system enhancements to the IWRS
• Build and maintain strong business partnerships with teams, functions and affiliates
• Serve as technical expert for all aspects of IWRS/IRT
• Consult with and influence multiple functions during protocol development and the study build process
• Assess patient management needs and implement an IWRS solution to simplify processing for increased site compliance
• Influence study randomization methods to ensure data collected and used during the trial is what was initially projected
• Collaborate to ensure that IWRS data meets the needs of the study and conforms to the standard data transfer methodologies / datasets
• Drive all aspects of the System Development Cycle to deliver validated, study-specific IWRS builds
• Provide ongoing support and maintenance for all Lilly clinical trials utilizing IWRS
• Ensure confidentiality and blinding is appropriately maintained at all times
• Drive innovation by proactively identifying ways for process optimization to improve day-to-day activities and practices
• Participate in and/or support the implementation of local/divisional/corporate projects, critical chain, and process improvement initiatives
• Take proactive measures to avoid or reduce crises

Benefits

• Eligibility to participate in a company-sponsored 401(k)
• Pension
• Vacation benefits
• Eligibility for medical, dental, vision and prescription drug benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Certain time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
• Company bonus eligibility depending on company and individual performance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree