Clinical Data Manager II (Canada)

at  Allucent

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.
We are looking for a Clinical Data Manager II (DM II) to join our A-team (hybrid*/remote). As a Clinical DM II at Allucent, you will assist in data management related activities of the Allucent Data Management (DM) department. This position supports and performs DM-related 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..

• Assist in DM-related tasks and collaborate with Lead DMs and relevant roles within Data Management (e.g. Clinical Programmers, Data Scientists).
• May act as primary contact for DM with all relevant parties, both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Biostatistics and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites)
• Provide feedback and status updates to Lead DM regarding progress, timelines, risk and quality and plan and when assigned as lead CDM, project resources based on assigned tasks and projects
• Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests
• Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements
• Provide support during clinical study database set-up, including eCRF design and database validation requirement and may lead these activities
• Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan)
• Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
• Create training materials for EDC users and provide project-specific training as required
• Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
• Participate in creating data cleaning strategy in consultation with applicable functional groups and assist in data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
• 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. May organize and lead Quality Review activities on behalf of lead DM.
• Support and/or manage the database maintenance, lock and close-out processes and procedure
• May participate in conference calls and/or meetings with vendors and sponsors
• Recognize and solve potential problems and evaluate effectiveness
• Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date
• Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned
• 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
• Contribute to other areas of business as required