Central Monitor II

Jobtailor; Deutschland; Remote; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a remote Clinical Data Reviewer to support Phase I–IV trials and non-interventional studies. You will review patient data, ensure regulatory compliance, and safeguard patient safety and data integrity across sites and procedures.

Responsibilities include data query generation, risk assessment, DSU involvement, and collaboration with cross-functional teams. Travel is limited to trainings and investigator meetings.

Qualifikationen

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and regulatory requirements.
• Excellent verbal and written communication skills.
• Strong analytical skills and data visualization proficiency.
• Less than 10% travel for trainings and investigator meetings.

Aufgaben

• Perform remote patient data review activities for Phase I-IV clinical research and non-interventional studies.
• Assess compliance with protocols, ICH-GCP and applicable regulatory requirements.
• Ensure patient safety and data integrity using various technologies.
• Review protocols, critical data and process risks, safety risks, and data integrity risks.
• Review patient data listings and visualizations to confirm eligibility and identify deviations, safety concerns, and data issues.
• Communicate and elevate serious issues to the project team and develop action plans with guidance.
• Document observations and write queries, protocol deviations, or action items in appropriate systems.
• Verify investigational product dispensing and administration, laboratory and other procedures, and current and complete eTMF data.
• Document activity completion through tracking, reporting, and required project documents.
• Manage patient- and site-level activities to meet project objectives, deliverables, and timelines.
• Adapt to changing priorities with oversight from the Lead CRA/LCMDA.
• Prepare for and attend investigator and sponsor meetings.
• Participate in project staff meetings and clinical training sessions.

Kenntnisse

Verbal communication

Written communication

Analytical thinking

Cross-functional collaboration

Problem solving

Adaptability

Team collaboration

Ausbildung

Bachelor’s degree or RN in a related field

Tools

MS Excel

Analytical Data Visualization Tools

ETMF Systems

Jobbeschreibung

• Perform remote patient data review activities for Phase I-IV clinical research and/or non-interventional studies
• Assess compliance with protocols, ICH-GCP, and applicable local and federal regulatory requirements
• Ensure patient safety and data integrity using various technologies
• Review protocols, critical data and process risks, safety risks, and data integrity risks
• Review patient data listings and visualizations to confirm eligibility and identify protocol deviations, patient safety concerns, data integrity issues, and inaccurate or missing data
• Assess factors affecting patient safety and clinical data integrity at investigator and physician sites
• Communicate and elevate serious issues to the project team and develop action plans with guidance
• Document observations and write queries, protocol deviations, or action items in appropriate systems
• Verify investigational product dispensing and administration, laboratory and other procedures, and current and complete eTMF data
• Document activity completion through tracking, reporting, and required project documents
• Manage patient- and site-level activities to meet project objectives, deliverables, and timelines
• Adapt to changing priorities with oversight from the Lead CRA/LCMDA
• Prepare for and attend investigator and sponsor meetings
• Participate in project staff meetings and clinical training sessions

Requirements

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Mastery of MS Excel, including sorting, filtering, calculating, and pivoting
• Proficiency with Analytical Data Visualization Tools, including adjusting visualizations and selecting data subsets
• Excellent verbal and written communication skills
• Ability to inform, influence, and communicate cross-functionally
• Strong analytical skills
• Developing therapeutic expertise
• Less than 10% travel, limited to trainings and investigator meetings

Core Competencies

Demonstrates expertise in clinical data review and compliance with ICH-GCP and regulatory requirements, ensuring patient safety and data integrity through effective communication and analytical skills.

Highest-signal resume keywords

• Clinical Data Review
• ICH-GCP Compliance
• Analytical Data Visualization
• MS Excel Mastery
• Verbal And Written Communication

ATS Optimization Keywords

Hard Skills

• Clinical Research
• Data Integrity Assessment
• Protocol Review
• Risk Assessment
• Data Query Documentation
• ETMF Management
• Patient Safety Monitoring
• Regulatory Compliance
• Data Analysis
• Protocol Deviation Identification

Soft Skills

• Cross-Functional Communication
• Analytical Thinking
• Problem Solving
• Adaptability
• Team Collaboration

Industry Keywords

• Good Clinical Practice
• Phase I-IV Clinical Research
• Regulatory Requirements
• Patient Data Review
• Clinical Training

Tools & Technologies

• Analytical Data Visualization Tools
• MS Excel
• ETMF Systems