Senior Clinical Data Manager

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

• Conduct continuous evaluations of clinical trial data to verify its accuracy, completeness, and consistency.

• Detect, investigate, and rectify data inconsistencies through effective query management.

• Execute both manual and system-based data reviews in line with study protocols and Data Management Plans (DMPs).

• Work collaboratively with Clinical Operations, Biostatistics, Programming, and Medical Monitoring teams to facilitate data cleaning efforts.

• Engage in database locking activities and ensure data is prepared for interim and final analyses.

• Maintain study documentation in adherence to regulatory standards and internal Standard Operating Procedures (SOPs).

• Oversee and manage user access within clinical data management platforms such as Medidata Rave.

• Process access requests, alterations, and terminations as per established protocols.

• Ensure appropriate role-based access and system permissions are granted.

• Keep audit-ready documentation associated with user access activities.

• Assist with periodic access reviews and compliance audits.

• Provide support for system user training and troubleshooting as required.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Health Sciences, or a related discipline (or equivalent experience).

• At least 4 years of experience in clinical data management.

• Proven hands-on experience in data review within clinical trials.

• Proficient in Medidata Rave.

• Solid understanding of clinical data management processes and regulatory standards (GCP, FDA, ICH guidelines).

• Experience in query management and resolving discrepancies.

🏝️ Benefits

• Comprehensive health benefits package.

• Opportunities for professional development and training.

• Flexible work arrangements.

• Supportive and collaborative work environment.