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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 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. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Purpose:

The Engagement Solutions role is key in supporting Principal Investigators (PIs) and site teams during the enrollment, maintenance, and close-out phases of clinical trials. As an expert capability, this role is essential to support the enablement of efficient and timely trial execution, strong site engagement, and optimized patient recruitment and retention. The role works within Investigator Engagement and cross-functionally with clinical team partners to anticipate, identify and remove operational barriers, manage documentation and systems requirements internally and also support these externally to ensure sites are operationally and administratively prepared throughout the active life of a trial. Issue management is handled at trial level, monitoring for patterns and systemic areas of challenge and issues and implementing solutions at the highest level for efficiency and effectiveness.

Reporting to the Director/Associate Director Clinical Research Engagement Solutions, this non-traveling position is focused on supporting sites through virtual channels. The role maintains frequent communication with trial site staff to ensure they have the tools, information, and support they need to execute the trial. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

Primary Responsibilities:

Clinical Trial Execution & Site Support

+ Serve as the primary point of contact for site administration and logistical needs during enrollment and maintenance and Data Base Lock (DBL).

+ Collaborate closely with PIs and study coordinators to troubleshoot technical and administrative activities and issues flagged directly or indirectly (e.g. through the Clinical Research Liaisons)

+ Ensure timely site support and sustained engagement through consistent communication, proactive problem-solving, and appropriate follow-up.

+ Track and monitor documentation and systems information to ensure compliance and quality standards are maintained.

+ Support protocol amendment releases, mass mailings and communications and providing guidance and documentation as needed.

+ Assist sites with navigation or troubleshooting of sponsor systems (e.g., IRT, EDC, eTMF, CTMS) and escalate complex issues to system Subject Matter Experts (SMEs).

+ Support dissemination of training materials related to protocol changes, systems updates, or new tools introduced during enrollment/maintenance.

+ Field questions and provide refresher guidance to sites on processes such as eCRF entries, IWRS use, SIP data entry.

Regulatory & Documentation Oversight

+ Support maintenance and update of the Trial Master File (TMF) with essential enrollment and maintenance documentation to ensure inspection readiness.

+ Ensure documentation of patient-related activities, deviation handling, and site correspondence aligns with GCP and internal SOPs.

+ Flag inconsistencies or delays in data entry, document completion, or other quality-related indicators for follow-up.

+ Support sponsor audits and inspections by preparing and providing site interaction documentation as needed.

Operational Efficiency & Collaboration

+ Collaborate with monitors, CRLs, and cross-functional teams to identify unique and trending needs, operational risks, and site administrative feedback.

+ Utilize internal tracking tools and systems to ensure real-time visibility into site status/compliance.

+ Provide input into continuous improvement efforts by sharing insights and feedback from sites.

+ Prioritize workload based on study milestones, enrollment timelines, and site needs.

+ Design and implement solutions to create lasting fixes through automation, process change or quality improvements.

**Minimum Qualification Requirements** :

+ Bachelor’s degree preferably in a scientific or health related field

+ Minimum of two (2) years pharmaceutical industry OR clinical research experience

+ 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

Other Information/Additional Preferences:

+ Systems experience (Veeva, TMF) highly preferred

+ Understanding of the overall clinical development paradigm

+ Applied knowledge of customer service and/or project management processes and skills

+ Appreciation of/experience in compliance-driven environment

+ Effective communication, negotiation and problem solving skills

+ Self-management and organizational skills

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$63,000 - $140,800

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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