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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 39,000 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.
The IWRS Technology and Innovation Associate is responsible for all aspects of the 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 role will also have a technical focus and is responsible for working closely with IT to propose and implement innovative IT solutions to support the portfolio. For these IT solutions, the person in this role will act as the business project lead responsible for business requirements, user acceptance testing, procedures, and training materials. Some coding and development will also be required.
Partner with medical teams, key internal business partners, and third parties to enable clinical research
Collaborate with Clinical Trial Demand Managers and Supply Managers to help facilitate optimal Supply Planning
Provide IWRS expertise during the Study Development Process and attend key meetings
Act as liaison between various customer groups to ensure timelines are met
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
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, CTMS, etc.)
Collaborate closely with IT to ensure the business needs for the proposed IT solutions are fully understood
Partner with business functions and IT on defining the business requirements for the IT solution
For IT solutions, act as the business project lead responsible for business requirements, data setup, and user acceptance testing
Consultation, study set-up and execution
Build and maintain effective business partnerships with teams, functions and affiliates
Understand system functionalities, including capabilities and limitations, for Lilly’s internal IWRS
Participate in Study Development Process to review study-specific protocol requirements and establish implementation timelines
Participate in all aspects of the System Development Cycle, including but not limited to:
Gathering and defining study-specific system requirements;
Coordinating and executing study set-up process; and
Ensuring timelines are met according to agreed-upon system-need dates.
Provide a validated study-specific IWRS build that meets protocol requirements, customer specifications, and regulatory requirements
Provide ongoing support and maintenance for all Lilly clinical trials utilizing IWRS
Ensure confidentiality and blinding is appropriately maintained at all times
Perform SQL code development as necessary to support study needs
Proactively identify ways 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 six sigma projects, critical chain, and other 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
Minimum 3 years experience in an IT or computer system support role
Minimum of 2 years experience in clinical trials (CDO, CTMS, etc) and/or 5 years experience in drug development in areas intersecting with clinical data management (e.g. clinical operations, statistics, information technology, health outcomes, pharmacokinetics/pharmacodynamics, etc.)
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Demonstrated knowledge of clinical programming processes and technology
Demonstrated knowledge of programming languages
Prior experience with IVRS / IWRS systems
Demonstrated effectiveness in influencing across teams and management levels to drive process improvements and influence decisions
Excellent written and verbal communication skills
Deep understanding of various clinical trial protocol designs and their relationship to IWRS development
Must speak fluent in English
Work outside of core hours may be required to support the portfolio across the globe
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.