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# Clinical Data Systems - Study Build Lead

- **Company:** Collabera
- **Location:** North Chicago, IL, United States
- **Experience:** Expert
- **Salary:** $93,600.0 - $104,000.0
- **Contract:** Temporary contract
- **Skills:** Clinical Data Management, Clinical Data Repository, Data Governance, Electronic Data Capture, Data Streaming, Systems Integration, Information Technology, Veeva
- **Published:** August 21, 2026
- **Apply:** https://www.collabera.com/submit-resume/

## About the Role

o Bachelor's degree in Business, Management Information Systems, Computer Science, Life Sciences, or equivalent experience.
o Seven or more years of hands on technical study build experience in electronic data capture systems.
o Required hands on technical study build experience with Medidata Rave.
o In depth knowledge of clinical trial processes.
o Required in depth knowledge of Clinical Data Acquisition Standards Harmonization.
o Strong knowledge of Study Data Tabulation Model.
o Experience with clinical trial system design, configuration, delivery, and integration.
o Demonstrated ability to influence stakeholders without direct authority.
o Experience working effectively in a matrixed environment.
o Strong communication, analytical, problem solving, and organizational skills.
Preferred Qualifications:
o Master's degree.
o Technical study build experience with Veeva EDC.
o Experience with Interactive Response Technology systems.
o Experience with electronic Patient Reported Outcomes systems.

## Description

o This role provides technical leadership for the design, development, and delivery of clinical trial systems and data standards.
o The position supports study level and program level activities across clinical development programs.
o The role ensures clinical systems meet protocol requirements, data standards, regulatory expectations, quality standards, and end user needs.
o The successful candidate will coordinate technical study build activities, system integrations, timelines, dependencies, and quality requirements.
o This position also contributes to process improvement, innovation, coaching, mentoring, and organizational development initiatives., o Lead technical study build activities within electronic data capture clinical trial systems.
o Design and develop clinical trial systems based on protocol requirements, clinical data standards, and established methodologies.
o Ensure clinical system designs follow applicable standards and support effective functionality, user experience, and data flow.
o Coordinate the delivery of new clinical systems, system integrations, and required system changes.
o Use project management tools to monitor study progress, timelines, dependencies, risks, issues, and deliverables.
o Identify issues that may affect study timelines or quality and develop appropriate solutions.
o Collaborate with Clinical Data Operations and cross functional teams to achieve program and study objectives.
o Ensure assigned work products are aligned with upstream and downstream dependencies.
o Support consistency across therapeutic areas and clinical development programs.
o Ensure adherence to Good Clinical Practice, International Council for Harmonisation guidelines, applicable regulations, standard operating procedures, and quality standards.
o Stay current with evolving regulations, guidelines, and policies related to clinical development.
o Contribute to the development and continuous improvement of clinical system design methodologies.
o Coach and mentor team members and support their technical skill development.
o Lead or contribute to innovation and process improvement initiatives.


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