CTMS Operations Analyst

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

📋 Description

• Populate entries in the CTMS (Clinical Trial Management System) including visits, procedures, schedules, financial elements, and site personnel in accordance with company standards; prepare and transfer builds to the CTMS Operations Manager for final review and acceptance.

• Execute quality control checklists for builds, validate configurations and data, document defects with reproducible steps, remediate issues when possible, and escalate critical defects to the Manager or vendor. Monitor metrics for first-pass acceptance and defect remediation.

• Provide daily technical support for CTMS to Study Start-Up (SSU), Source, Study Ops, Site Network, and other Care Access users (including access requests, role/tag maintenance, and runbook guidance); conduct study-specific CTMS training as assigned.

• Generate standard CTMS reports and operational dashboards utilized by SSU/Study Ops; perform ad-hoc data queries to facilitate study preparedness and cross-functional decision-making.

• Keep build checklists, runbooks, and training materials updated; suggest process enhancements that minimize rework and elevate build quality and efficiency.

• Ensure accurate build documentation and maintain audit trails for study readiness and compliance purposes.

• Assist the CTMS Operations Manager with vendor ticketing and incident tracking for escalated issues.

• Support the onboarding and training of new CTMS Analysts and temporary personnel.

⛳️ Requirements

• Proficient understanding of CTMS configuration and study-build processes (experience with Conductor, Florence, Veeva, or similar CTMS is preferred).

• Strong attention to detail with experience in executing quality control/checklist tasks.

• Capability to run and interpret CTMS exports/queries and convey results to non-technical stakeholders.

• Practical experience in creating operational reports and dashboards (using Conductor, Excel, BI tools).

• Strong written and verbal communication skills for user support and cross-functional collaboration.

• Familiarity with ICH-GCP, SOPs, and audit processes.

• Bachelor's degree preferred (or equivalent experience).

• 2-4 years of experience with CTMS/platform or clinical systems, including a minimum of 1 year directly supporting CTMS, study builds, or clinical data operations.

• Preferred certifications: CTMS platform/certification training, GCP/clinical research certifications, or relevant technical certifications.

🏝️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays

• Medical, dental, and vision insurance plan options