Clinical Data Manager II

This is a fully remote position, open to applicants in India.

📋 Description

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

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

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

• Collaborate with multidisciplinary teams (Clinical Operations, Biostatistics, Programming, Medical Monitoring) to facilitate data cleansing efforts.

• Engage in database lock procedures and confirm data preparedness for interim and final analyses.

• Keep study documentation aligned 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, changes, and terminations following established protocols.

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

• Maintain documentation that is ready for audits regarding user access activities.

• Aid in regular access reviews and compliance assessments.

• Provide assistance with user training and troubleshooting for the system as required.

⛳️ Requirements

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

• At least 2 years of experience in clinical data management.

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

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

• Experience with the Cloud Administration module is preferred.

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

• Familiarity with query management and data discrepancy resolution.

🏝️ Benefits

• Comprehensive health insurance plans.

• Opportunities for professional development and training.

• Flexible working hours and remote work options.

• Competitive salary and performance-based bonuses.