Advisor - Clinical Study Build Programmer

Role 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

Qualifications

• Required: Bachelor's degree in a scientific, technical, or healthcare-related STEM field (e.g., Computer Science, Biology, Statistics, Health Informatics).
• Required: 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.
• Preferred: Hands-on experience with at least one major Electronic Data Capture (EDC) system (e.g., Medidata Rave, Oracle Clinical, Veeva Vault Clinical).
• Preferred: Familiarity with clinical trial processes, ICH-GCP guidelines, and 21 CFR Part 11 regulations.
• Preferred: Strong analytical and problem-solving skills with meticulous attention to detail.
• Preferred: Excellent communication (written and verbal) and interpersonal skills, with the ability to collaborate effectively with diverse teams.
• Preferred: Ability to manage multiple tasks, prioritize effectively, and work independently in a dynamic environment.
• Preferred: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Preferred: Experience with SQL, SAS, or other programming languages is a plus.

Skills

• Hands-on experience with at least one major Electronic Data Capture (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 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.

Education

• Bachelor's degree in a scientific, technical, or healthcare-related STEM field (e.g., Computer Science, Biology, Statistics, Health Informatics).