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 accuracy, completeness, and consistency.

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

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

• Collaborate with teams in Clinical Operations, Biostatistics, Programming, and 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 alignment with regulatory standards and internal Standard Operating Procedures (SOPs).

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

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

• Guarantee appropriate role-based access and system permissions.

• Keep audit-ready documentation pertaining to user access activities.

• Assist in periodic access reviews and compliance evaluations.

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

⛳️ Requirements

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

• A minimum of 4 years of experience in clinical data management.

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

• Proficiency in Medidata Rave (familiarity with building knowledge is advantageous but not mandatory).

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

• Experience with query management and resolving discrepancies.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career growth.

• Flexible working arrangements and a supportive work environment.