Care Access - CTMS Operations Analyst
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Requirements
• Working knowledge of CTMS configuration and study-build processes (experience with Conductor, Florence, Veeva, or comparable CTMS preferred). • Strong attention to detail and experience executing QC/checklist work. • Ability to run and interpret CTMS exports/queries and translate results for non-technical stakeholders. • Practical experience creating operational reports and dashboards (Conductor, Excel, BI tools). • Effective written and verbal communication for user support and cross-functional coordination. • Familiarity with ICH-GCP, SOPs, and audit processes. • Certifications/Licenses, Education, and Experience: • Bachelor’s degree preferred (or equivalent experience). • 2-4 years of CTMS/platform or clinical systems experience, with 1+ years directly supporting CTMS, study builds, or clinical data operations. • Preferred certifications: CTMS platform/certification training, GCP/clinical research certifications, or relevant technical certifications. • How We Work Together • Location: Remote within Poland • Location • Travel: Minimal (<10%), planned in advance. • Travel
Responsibilities
• How You'll Make An Impact • Populate CTMS entries (visits, procedures, schedules, financial elements, site personnel) according to company requirement; prepare and hand off builds to the CTMS Operations Manager for final review/acceptance. • Execute build QC checklists, validate configuration and data, log defects with reproducible steps, remediate where possible, and escalate gating defects to the Manager or vendor. Track first-pass acceptance and defect remediation metrics. • Provide day-to-day CTMS technical support for Study Start-Up (SSU), Source, Study Ops, Site Network and other Care Access users (access requests, role/tag maintenance, runbook guidance); deliver study-specific CTMS training as assigned. • Produce standard CTMS reports and operational dashboards used by SSU/Study Ops; perform ad-hoc data pulls to support study readiness and cross-functional decision-making • Maintain build checklists, runbooks, and training materials; propose process improvements that reduce rework and improve build quality and throughput. • Maintain accurate build documentation and audit trails for study readiness and compliance. • Support the CTMS Operations Manager in vendor ticketing and incident tracking when escalated. • Assist with onboarding and training of new CTMS Analysts and temporary staff.
Benefits
• Paid Time Off (PTO) and Company Paid Holidays • Medical, dental, and vision insurance plan options • Diversity & Inclusion • We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
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