Clinical Data Manager I (India)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

The Clinical Data Manager I (CDM1) assists in data management related activities of the Allucent Data Management (DM) department.  

This position supports other Allucent Clinical Data Managers (CDMs) and Clinical Programmer(s) and performs DM activities from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.   

In this role your key tasks will include:

• Assist in DM related tasks and collaborate with Lead DMs and relevant roles within Data Management (e.g. Clinical Programmers, Data Scientist) as well as with Clinical Monitoring staff. May be in contact with other functional groups (e.g Project Management, Clinical Operations/Monitoring, Biostatistics) 
• Provide feedback and status updates to Lead DM regarding progress, timelines, risk and quality  
• Monitor tasks against budget, forecasts and timely raise/alert changes of scope requests  
• Support the development, review and maintenance project-specific DM documents including data management plan (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements  
• Provide support during eCRF design and database validation requirements 
• Participate in database User Acceptance Testing (UAT) related tasks 
• Create training materials for EDC users 
• Review and validate clinical data to ensure consistency, accuracy, integrity and completeness  
• Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data  
• Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance  
• Support and conduct Quality Review checks during study and document findings   
• Support the database maintenance, lock and close-out processes and procedure 
• Signal, recognize and solve potential problems and evaluate effectiveness 
• Support the maintenance of DM study  documentation on an ongoing basis and ensure that all filing is up to date  
• Support collection and creation of necessary documentation to support internal and external audits 
• Help to align data management and clinical programming best practices, standards and conventions within the company 
• Propose and support initiatives for improving efficiency.
• Actively support to staff learning & development within the company 
• Share relevant information at applicable DM departmental meetings.
• Contribute in the field of Clinical Data Management activities to the evaluation/improvement of processes and procedures within the Quality Management System 
• Assure good communication and relationships with (future) clients