Advisor - Clinical Study Build Programmer
Eli Lilly and Company
2 months ago
Remote friendly (Indianapolis, IN)
United States
$126,000 - $204,600 USD yearly
Clinical Research and Development
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 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, 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 study build activities comply with relevant regulatory requirements (e.g., GCP, 21 CFR Part 11) and internal 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 4 years of experience in clinical data management or clinical systems development in the pharmaceutical/biotechnology industry, plus at least 2 years of supervisory/team management experience.
Additional Preferences:
- Hands-on experience with at least one major EDC system (e.g., Medidata Rave, Oracle Clinical, Veeva Vault Clinical).
- Familiarity with clinical trial processes, ICH-GCP guidelines, and 21 CFR Part 11 regulations.
- Strong analytical/problem-solving skills and attention to detail.
- Excellent written/verbal communication and interpersonal skills.
- Ability to manage multiple tasks, prioritize, and work independently.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Experience with SQL, SAS, or other programming languages (plus).
Benefits:
- Company bonus (for full-time equivalent employees, depending on company and individual performance).
- Eligibility to participate in a company-sponsored 401(k); pension; vacation.
- 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, employee clubs/activities).
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 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, 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 study build activities comply with relevant regulatory requirements (e.g., GCP, 21 CFR Part 11) and internal 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 4 years of experience in clinical data management or clinical systems development in the pharmaceutical/biotechnology industry, plus at least 2 years of supervisory/team management experience.
Additional Preferences:
- Hands-on experience with at least one major EDC system (e.g., Medidata Rave, Oracle Clinical, Veeva Vault Clinical).
- Familiarity with clinical trial processes, ICH-GCP guidelines, and 21 CFR Part 11 regulations.
- Strong analytical/problem-solving skills and attention to detail.
- Excellent written/verbal communication and interpersonal skills.
- Ability to manage multiple tasks, prioritize, and work independently.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Experience with SQL, SAS, or other programming languages (plus).
Benefits:
- Company bonus (for full-time equivalent employees, depending on company and individual performance).
- Eligibility to participate in a company-sponsored 401(k); pension; vacation.
- 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, employee clubs/activities).