CTMS Operations Analyst
New
C
Care AccessHealthcare
Poland (Remote)Full-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 2-4 years
- Required Skills
- GCPMicrosoft Excel
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.
- 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.
Responsibilities
- 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.
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