Associate Director - IWRS Design and Development

Eli Lilly and Company • Indianapolis, IN

14d

About The Position

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. Organization Overview: 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. Main Purpose and Objectives of 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

• Bachelors degree and 3 years' experience in clinical trials (CDO, Product Delivery, etc.) and/or 7 years' experience in drug development in areas intersecting with clinical data management (e.g. clinical operations, statistics, information technology, health outcomes, pharmacokinetics/pharmacodynamics, etc.); alternatively, a high school diploma and 5 years' experience in clinical trials and/or 7 years' experience in drug development.
• 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 (timeline, scope, resources, time management).
• 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; 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.
• Clinical Trial Project Managers – Assess patient management needs and implement an IWRS solution to simplify processing for increased site compliance
• Statisticians – Influence study randomization methods, in particular, stratification factors and ratios, to ensure data collected and used during the trial is what was initially projected.
• Data Sciences – Collaborate to ensure that IWRS data meets the needs of the study and conforms to the standard data transfer methodologies / datasets. If necessary, propose changes to ensure that separate interfaces are not required to support a single trail design. As necessary, create reusable solutions to share information between systems such as eDC and central labs to eliminate redundancy and entry errors.
• Drive all aspects of the System Development Cycle to deliver validated, study-specific IWRS builds. This includes, but is not limited to: Gathering and defining study-specific system requirements. Coordinating and executing study set-up process. Ensuring timelines are met to support the portfolio and enable FPV.
• Provide ongoing support and maintenance for all Lilly clinical trials utilizing IWRS.
• Provide consultation and expertise for studies utilizing a Third Party’s 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, and actively communicate opportunities to peers and leadership team.
• 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. When emergencies occur, identify root cause of issues and communicate countermeasures and lessons learned.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees