Contract Clinical Systems Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Engage in the planning, design, configuration, and implementation of new clinical systems, as well as enhancements to existing applications; coordinate and participate in the analysis of system requirements, user acceptance testing, and system improvements when necessary.

• Provide support and enhancements for the Clinical Data Repository (CDR) system.

• Collaborate with end users and subject matter experts (SMEs) to establish business requirements for clinical data visualization and identify necessary data elements.

• Develop and maintain clinical data analytics, including patient profiles and study dashboards.

• Collaborate with clinical systems vendors and Contract Research Organizations (CROs) to transfer, integrate, and transform clinical and operational data into Cytokinetics systems.

• Create and maintain automation scripts for clinical data.

• Deliver training on various clinical systems as required.

• Assist in the administration of clinical systems, including user management.

• Serve as an internal clinical systems subject matter expert to support end users.

⛳️ Requirements

• A Bachelor’s degree in information technology, computer science, computer engineering, statistics, or bioinformatics, coupled with 3+ years of relevant experience in supporting clinical systems within the biotech or life sciences sector, including data cleansing, analytics, and reporting.

• Proficiency with EDC (Medidata Rave) and/or clinical data repository (CDR) systems.

• Experience with MicroStrategy (dashboard, visualization, and report development) or similar data review tools.

• Skilled in using Iron Python and SQL to develop and maintain scripts that automate tasks.

• Knowledge of database concepts, data validation, and data modeling processes for both internal and external sources.

• Experience with data integration and ETL (extract, transform, load) processes.

• Understanding of clinical trial data and regulations, including CDISC, Good Clinical Practice, and 21 CFR Part 11.

• Proven experience in developing business specifications and requirements, as well as conducting user acceptance testing for computer systems.

• Background in clinical data management is preferred.

• Strong interpersonal skills are essential.

• Excellent written and verbal communication skills are required.

• Demonstrated analytical and problem-solving capabilities are necessary.

• A keen attention to detail is required.

• Strong organizational skills and the ability to manage multiple tasks effectively.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holidays.

• Opportunities for professional development and career advancement.

• Collaborative and inclusive work environment.