Clinical Database Programmer

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

The Lead Clinical Data Science Programmer works as part of a cross-functional project team to design, implement, and maintain Medidata Rave clinical databases and systems used to collect, review, and clean data across Phase I–IV clinical trials. This role plays a key part in driving operational excellence through automation, standardization, and innovation in database build and maintenance activities.

The role actively identifies and implements solutions to reduce database set-up timelines, including increased automation, and leads or contributes to evaluation and improvement initiatives related to data management applications and system integrations. Development and continuous improvement of standards, templates, and processes are core expectations, along with providing strong technical leadership and innovation.

Technical & Operational Leadership

• Lead and manage clinical database programming activities for multiple studies of varying complexity, ensuring adherence to established processes, standards, timelines, and quality expectations.

• Design, develop, test, and maintain clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, and custom functions.

• Provide study-level technical support and mentorship to junior team members, resolving complex technical issues and evaluating alternative solutions.

• Create, review, and approve technical specifications and develop complex programs and technical solutions for data management systems.

• Support database build activities including eCRFs, change requests, edit checks, derivations, custom functions, interface configurations, and data migrations.

• Track and manage issues within Medidata applications, working collaboratively with vendors and escalating risks as appropriate.

• Support user access management via iMedidata and Cloud Administration.

• Assist in the management and maintenance of medical coding dictionaries, including MedDRA and WHODrug.

• Resolve data anomalies and quality issues, ensuring compliance with regulatory and internal quality standards.

Process Improvement & Documentation

• Contribute to the development of departmental documentation, including training materials, SOPs, work instructions, and process guides.

• Continuously seek opportunities to improve processes, templates, and tools to enhance efficiency, scalability, and data quality.

• Maintain comprehensive supporting documentation to ensure traceability, inspection readiness, and compliance.

• Capture and communicate lessons learned, best practices, and frequently asked questions.

Vendor & Stakeholder Management

• Oversee CRO/vendor activities related to outsourced data management systems, ensuring compliance with industry best practices, quality standards, and timelines.

• Maintain regular communication with external partners, proactively addressing issues and mitigating risks.

• Collaborate closely with cross-functional teams including Clinical Operations, Biostatistics, Safety, Medical, and IT.

Strategic Contribution

• Help end users understand technical challenges and analyze current processes to ensure solutions are fit-for-purpose and aligned with study needs.

• Contribute to system selection, implementation, and enhancement initiatives.

• Support delivery across approximately 18–20 studies per year.

• Bachelor’s degree in computer science, Life Sciences, or a related field.

• 8+ years of experience in the pharmaceutical, biotech, or CRO industry.

• 6+ years of hands-on experience in clinical trial database design and management using Medidata Rave, including Custom Function programming.

• Strong experience with eCRF design, database specifications, and data validation checks.

• Experience with QC, UAT, platform testing, and development/execution of test scripts.

• Solid understanding of the Drug Development Process, SDLC, Computer System Validation, FDA regulations, ICH-GCP, and global Health Authority guidelines.

• Proven experience supporting clinical data development, validation, execution, maintenance, and documentation for regulatory submissions.

• Experience working in Agile or hybrid development environments.

• Strong verbal and written communication skills with the ability to collaborate across global, cross-functional teams.

• Demonstrated ability to prioritize and manage multiple studies and deliverables.

• Familiarity with JReview and Business Objects.

Preferred

• Knowledge of Visual Basic, SAS, or other object-oriented programming languages.

• Experience with additional Medidata modules (e.g., RTSM, CTMS, Coder, Lab Admin, TSDV) and system integrations.

• Understanding of relational databases and data standards such as CDISC/CDASH.

• Advanced MS Office skills (Excel, PowerPoint, Word), including complex data analysis and pivot tables.

• Strong analytical, problem-solving, and critical-thinking skills.

• Experience providing training, mentoring, and subject-matter expertise to team members.

• Ability to innovate and drive transformation toward more efficient, scalable data management solutions.

• Comfortable working independently within a collaborative, fast-paced global environment.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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