CTMS Operations Analyst

Accountabilities: • Configure CTMS study and site builds, including visits, procedures, schedules, financial elements, and site personnel, according to established requirements.

• Prepare completed builds and hand them over for final review and acceptance by the CTMS Operations Manager.

• Execute build quality-control checklists, validate configurations and data, identify defects, document reproducible steps, and remediate issues where possible.

• Escalate critical or gating defects to the appropriate manager or platform vendor and track defect remediation and first-pass acceptance metrics.

• Provide day-to-day technical CTMS support to Study Start-Up, Study Operations, Source, Site Network, and other internal users.

• Manage access requests, role and tag maintenance, and provide guidance based on established runbooks and procedures.

• Deliver study-specific CTMS training to users and contribute to onboarding and training new CTMS analysts and temporary staff.

• Produce standard CTMS reports and operational dashboards to support study readiness and operational decision-making.

• Perform ad-hoc data queries and exports and translate findings into useful information for non-technical stakeholders.

• Maintain build checklists, runbooks, training materials, documentation, and audit trails to support quality and compliance.

• Support incident tracking and vendor ticketing when issues require escalation.

• Identify and recommend improvements to processes, tools, templates, and workflows to reduce rework and improve build quality and throughput.

• Support platform governance, change-control activities, and enterprise reporting as required.

Requirements

• Bachelor’s degree preferred, or equivalent relevant professional experience.

• 2–4 years of experience in CTMS, clinical platforms, clinical systems, or related environments.

• At least 1 year of hands-on experience supporting CTMS platforms, study builds, or clinical data operations.

• Working knowledge of CTMS configuration and study-build processes.

• Professional experience with platforms such as Clinical Conductor, Florence, Veeva, or comparable CTMS solutions is preferred.

• Strong attention to detail and practical experience performing quality-control and checklist-based work.

• Ability to run and interpret CTMS exports and queries and communicate findings effectively to non-technical stakeholders.

• Experience creating operational reports and dashboards using CTMS platforms, Excel, BI tools, or similar technologies.

• Proficiency with data analysis and documentation, with a strong focus on accuracy and consistency.

• Familiarity with ICH-GCP principles, standard operating procedures, audit processes, and clinical research compliance.

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

• Good organizational and prioritization skills, with the ability to manage multiple tasks in a dynamic environment.

• Ability to work independently while contributing effectively within a collaborative team.

• Strong analytical and problem-solving capabilities, with a proactive approach to identifying and resolving issues.

• Fluency in English or the ability to communicate effectively in an international professional environment.

• CTMS platform training, GCP/clinical research certifications, or relevant technical certifications are advantageous.

• Willingness to travel occasionally for business requirements and in-person activities.

• Must reside in Brazil and be able to participate in occasional office visits when required.

• Work authorization must be available for Brazil; visa sponsorship is not available for this position.

Benefits

• Market-competitive salary.

• Medical insurance plan options.

• Dental insurance plan options.

• Vision insurance plan options.

• Predominantly remote work arrangement from Brazil.

• Flexibility to work remotely while participating in occasional in-person activities when required.

• Opportunity to contribute to clinical research operations and study readiness.

• Exposure to CTMS platforms, clinical systems, operational reporting, and platform governance.

• Opportunities to develop technical and clinical operations expertise.

• Collaborative environment with cross-functional clinical operations teams.

• Opportunities to contribute to process improvement, quality assurance, and operational efficiency.

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