Clinical Systems Specialist

Role: Clinical Systems Specialist (Contract) Duration: 6+ months renewable; long term Location: Remote, US Our client is seeking a Contract Clinical Systems Specialist to support the Clinical Systems team within Biometrics and Development Operations. This role is best suited for someone with a strong foundation in Clinical Data Management and experience supporting enterprise clinical systems, particularly Clinical Data Repositories (CDRs). The Clinical Data Repository (CDR) is the primary focus of this role. The consultant will serve as the internal subject matter expert supporting the CDR platform, working closely with clinical data managers, clinical operations, vendors, and CRO partners to ensure high-quality clinical data integration, reporting, and system functionality. This is not a software engineering or data science position. The ideal consultant understands clinical trial data and clinical systems, with enough technical expertise to support reporting, data investigations, system administration, and simple automation. Responsibilities Serve as the subject matter expert for the Clinical Data Repository (CDR), supporting day-to-day system functionality and enhancement. Partner with clinical data managers to support clinical data review and investigate data discrepancies using SQL and/or Python when needed. Collaborate with CROs and external vendors to support the transfer, integration, and quality of clinical trial data. Develop and maintain clinical dashboards, reports, and visualizations using tools such as Power BI, Tableau, or MicroStrategy. Support user acceptance testing (UAT), system validation activities, and implementation of new system functionality. Assist with clinical systems administration, including user access, security roles, and system configuration. Gather business requirements from end users and collaborate with cross-functional stakeholders to improve clinical systems and reporting capabilities. Provide user support and training for clinical systems as needed. Qualifications Bachelor's degree and at least 3+ years of experience supporting clinical systems within the biotechnology, pharmaceutical, or CRO industry. Must have a background in Clinical Data Management and understanding of clinical trial data workflow. Experience supporting a Clinical Data Repository (CDR). Experience working with EDC systems (Medidata Rave preferred) and clinical trial data integration. Experience building reports or dashboards using Power BI, Tableau, MicroStrategy, or similar reporting tool. Working knowledge of SQL and/or Python for data queries, discrepancy investigation, or simple automation scripts (advanced programming experience is not required). Experience with User Acceptance Testing (UAT), system validation, and business requirements gathering. Familiarity with GCP, CDISC standards, and 21 CFR Part 1. Strong communication, organization, and problem‑solving skills. Preferred Experience Experience supporting Saama Clinical Data Repository. Experience working directly with Clinical Data Managers and Development Operations teams. Experience supporting vendor‑managed clinical systems. Experience with user administration, security roles, and clinical systems configuration. Experience working with CROs and external technology partners. #J-18808-Ljbffr