Senior Clinical Data Manager

Jobtailor; Deutschland; Remote; EUR 52.000 - 76.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced Clinical Data Manager to ensure data accuracy and integrity across trials. You will review data, manage queries, and support database lock activities in collaboration with cross-functional teams.

The role requires hands-on Medidata Rave expertise, a solid understanding of GCP/ICH guidelines, and the ability to maintain audit-ready documentation and user access controls across systems.

Qualifikationen

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field.
• Minimum of 4 years of clinical data management experience
• Hands-on data review experience in clinical trials
• Proficiency in Medidata Rave
• Strong understanding of clinical data management processes and regulatory requirements (GCP, FDA, ICH)
• Experience with query management and discrepancy resolution

Aufgaben

• Perform ongoing review of clinical trial data to ensure accuracy, completeness, and consistency
• Identify, investigate, and resolve data discrepancies through query management
• Conduct manual and system-driven data reviews in accordance with study protocols and DMPs
• Collaborate with Clinical Operations, Biostatistics, Programming, and Medical Monitoring teams to support data cleaning activities
• Participate in database lock activities and ensure data readiness for interim and final analyses
• Maintain study documentation in compliance with regulatory requirements and internal SOPs
• Manage and maintain user access within clinical data management systems such as Medidata Rave
• Process access requests, modifications, and terminations according to established procedures
• Ensure appropriate role-based access and system permissions
• Maintain audit-ready documentation related to user access activities
• Support periodic access reviews and compliance checks
• Assist with system user training and troubleshooting as needed

Kenntnisse

Clinical Data Management

Medidata Rave Proficiency

Data Review Experience

Regulatory Compliance

Query Management

Ausbildung

Bachelor’s degree in Life Sciences/Health Sciences

Tools

Medidata Rave

Clinical Data Management Systems

Jobbeschreibung

• Perform ongoing review of clinical trial data to ensure accuracy, completeness, and consistency
• Identify, investigate, and resolve data discrepancies through query management
• Conduct manual and system-driven data reviews in accordance with study protocols and DMPs
• Collaborate with Clinical Operations, Biostatistics, Programming, and Medical Monitoring teams to support data cleaning activities
• Participate in database lock activities and ensure data readiness for interim and final analyses
• Maintain study documentation in compliance with regulatory requirements and internal SOPs
• Manage and maintain user access within clinical data management systems such as Medidata Rave
• Process access requests, modifications, and terminations according to established procedures
• Ensure appropriate role-based access and system permissions
• Maintain audit-ready documentation related to user access activities
• Support periodic access reviews and compliance checks
• Assist with system user training and troubleshooting as needed

Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field (or equivalent experience)
• Minimum of 4 years of clinical data management experience
• Demonstrated hands-on data review experience in clinical trials
• Proficiency in Medidata Rave
• Strong understanding of clinical data management processes and regulatory requirements (GCP, FDA, ICH guidelines)
• Experience with query management and discrepancy resolution

Core Competencies

Expertise in clinical data management, including data review, discrepancy resolution, and compliance with regulatory requirements. Proficient in using Medidata Rave for managing clinical trial data and ensuring data integrity.

Highest-signal resume keywords

• Clinical Data Management
• Medidata Rave Proficiency
• Data Review Experience
• Regulatory Compliance (GCP, FDA, ICH)
• Query Management

Hard Skills

• Data Review
• Discrepancy Resolution
• Data Cleaning
• Database Lock Activities
• User Access Management
• Audit-Ready Documentation
• System User Training

Soft Skills

• Collaboration
• Problem-Solving

Industry Keywords

• Clinical Trials
• Study Protocols
• Data Management Plans (DMPs)
• Access Requests
• Compliance Checks

Tools & Technologies

• Clinical Data Management Systems