Clinical Data and Systems Specialist

The Clinical Data and Systems Specialist is responsible for supporting global clinical studies through the management of clinical data, clinical systems, and related operational processes across the entire study lifecycle. This role ensures that study data is accurate, complete, compliant, and readily available for analysis, reporting, and regulatory purposes while maintaining the highest standards of data integrity and Good Clinical Practice (GCP).

Responsibilities

Manage clinical data activities from study start-up through database lock and study closeout; Review, clean, and validate clinical data while managing queries and ensuring data integrity; Support data entry, quality control processes, and controlled data workflows; Perform reconciliations between EDC/CDMS platforms and external data sources, including laboratories, imaging, ePRO/eCOA, devices, and vendors; Support clinical systems setup, user access management, User Acceptance Testing (UAT), validation activities, and compliance requirements; Maintain study documentation, trackers, action logs, deliverables, and supporting evidence to ensure traceability and inspection readiness; Generate reports, dashboards, listings, metrics, and data outputs to support study oversight and decision-making; Collaborate with cross-functional teams and external partners to resolve data and system-related issues; Identify opportunities for process improvement, automation, and technology-enabled solutions; Contribute to the development of standards, templates, training materials, and continuous improvement initiatives within the Clinical Data and Systems function.

Requirements

Bachelor's degree in Life Sciences, Health Sciences, Biomedical Engineering, Statistics, Data Science, Computer Science, or a related field; 2-4 years of experience in clinical data management, clinical systems, clinical research, or regulated data environments; Good Clinical Practice (GCP) certification (may be completed during onboarding); Strong Excel skills and experience working with structured data, reporting, data quality review, query management, and reconciliation activities; Familiarity with CRFs/eCRFs, clinical data workflows, and regulated documentation practices; Advanced English (C1 level or equivalent) and fluent Spanish; Strong analytical, organizational, problem-solving, and communication skills, with the ability to collaborate effectively across cross-functional teams.

Nice to have

Experience working with EDC/CDMS platforms and external clinical data systems; Knowledge of Power Query, Python, Tableau, Power BI, SQL, R, SAS, or similar analytics and reporting tools; Experience supporting UAT, system validation, access management, and compliance activities; Knowledge of CDISC, CDASH, ICH-GCP, 21 CFR Part 11, and risk-based validation principles; Experience within CRO, medical device, pharmaceutical, sponsor, or regulated clinical research environments; Master's degree or additional studies in Clinical Research, Data Science, Biomedical Informatics, Regulatory Affairs, or related fields; SCDM certification, clinical data management training, or related certifications