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.
Job Summary The Advisor, Clinical Study Build Programmer, contributes to the successful design and execution of clinical trials by developing and maintaining robust clinical study databases and associated systems. This role also ensures the study build team delivers on the assigned portfolio meeting quality and timeline expectations.
Responsibilities
- Collaborate with clinical teams, statisticians, and data managers to translate study protocols into effective clinical study database designs.
- Develop, configure, and validate clinical study databases using industry-standard Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
- Design and implement Edit Checks, Derivations, and Custom Functions within EDC systems to ensure data quality and integrity.
- Create and maintain study documentation, including Database Design Specifications, User Acceptance Testing (UAT) scripts, and validation reports.
- Provide technical support and training to clinical study teams on EDC system functionality and data entry best practices.
- Participate in the review and implementation of system upgrades, enhancements, and new technologies related to clinical data management.
- Ensure all study build activities comply with relevant regulatory requirements (e.g., GCP, 21 CFR Part 11) and internal standard operating procedures (SOPs).
- Manage timelines and deliverables for assigned study build activities, escalating issues as necessary.
- Manage a team of Study build programmers and possibly a group leader
- Support hiring and talent management for the group
Basic Requirements
- Bachelor's degree in a scientific, technical, or healthcare-related STEM field (e.g., Computer Science, Biology, Statistics, Health Informatics).
- Minimum of 4 years of experience in clinical data management or clinical systems development within the pharmaceutical or biotechnology industry along with at least 2 years of supervisory/team management experience.
Additional Preferences
- Hands-on experience with at least one major Electronic Data Capture (EDC) system (e.g., Medidata Rave, Oracle Clinical, Veeva Vault Clinical) is required.
- Familiarity with clinical trial processes, ICH-GCP guidelines, and 21 CFR Part 11 regulations.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Excellent communication (written and verbal) and interpersonal skills, with the ability to collaborate effectively with diverse teams.
- Ability to manage multiple tasks, prioritize effectively, and work independently in a dynamic environment.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Experience with SQL, SAS, or other programming languages is a plus.
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
$126,000 - $204,600
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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