Clinical Data Manager II

CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.

We are currently looking for a Clinical Data Manager II to join us remotely in Canada.

The Clinical Data Manager II (CDM) leads and coordinates Data Management (DM) deliverables 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.

The CDM II is a member of the Data Management staff and will:

• Serve as primary contact for DM with all relevant parties both internally (e.g. Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, external vendors, investigational sites)
• Plan and project the resources required including management of tasks, timelines, risk and quality
• Keep track on budget, forecasts and manage changes of scope requests
• Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan)
• Provide support on clinical study database set-up, including eCRF design and database validation requirements
• Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements
• 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
• Create data cleaning plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
• Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance etc.
• Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
• Assist in medical coding tasks as assigned
• Participate in conference calls and/or meetings with vendors and sponsors
• Recognize and solve potential problems and evaluate effectiveness

• Manage the database implementation, lock and close-out processes and procedures
• Maintain 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; participates in such audits assigned
• Help to align data management and clinical programming best practices, standards and conventions within the company

Requirements

• BSc/MSc degree in mathematics, (bio) statistics, data science & other applied sciences, life science, pharmacy or related subject
• Minimum 3 years’ work experience as Clinical Data Manager
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies
• Excellent MS. Office command
• Excellent written and verbal communication skills in English - and French is a plus