Senior Clinical Data Manager

📋 Description

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

• Detect, investigate, and address 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 cross-functional teams (Clinical Operations, Biostatistics, Programming, Medical Monitoring) to facilitate data cleaning efforts.

• Engage in database lock procedures and ensure data is prepared for interim and final analyses.

• Uphold study documentation in accordance with regulatory standards and internal Standard Operating Procedures (SOPs).

• Oversee and manage user access within clinical data management systems (e.g., Medidata Rave).

• Handle access requests, modifications, and terminations following established guidelines.

• Ensure that role-based access and system permissions are correctly assigned.

• Preserve audit-ready documentation concerning user access activities.

• Assist with regular access reviews and compliance audits.

• Provide support for system user training and troubleshooting when necessary.

⛳️ 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.

• Familiarity with Medidata Rave (knowledge of build processes is advantageous but not essential).

• Strong grasp of clinical data management procedures and regulatory standards (GCP, FDA, ICH guidelines).

• Experience in query management and resolving discrepancies.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and further training.

• Flexible working hours and remote work options.

• Supportive work environment with a focus on work-life balance.