Project Data Manager

Ergomed•Toronto, ON

1d•Remote

About The Position

The Project Data Managers (PDM) within the ERGOMED Data Management (DM) department has full responsibility for the successful planning, execution, monitoring, control, and closure of multiple projects. The Project Data Manager represents a position under the direction of the Manager, Data Management.

Requirements

5 – 8 years’ experience in data management at a pharmaceutical, biotech, or research facility.
Experience in working with EDC systems (e.g. Merative Zelta, Medrio, Medidata RAVE)
Proficiency in computer applications: Windows, Excel, Word, Outlook etc.

Responsibilities

Independently lead and delegate tasks to ensure timely completion of project activities to project timelines, quality, and budget
Serve as the primary point of contact for internal teams and external vendors
Conduct internal quarterly audits and ensuring data submission readiness
Manage escalations and study complexities with confidence
Work with PMs to review, forecast budget; ensure study demands / hours / cost / deliverables are in line with budget line items
Provide feedback to other project team members and managers to improve the deliverables
Monitor project risks and implement mitigation strategies
Thorough knowledge of the end-to-end reporting process (data management, statistics, medical writing)
Oversee database build and migration and ensure a quality and timely deliverable
Work with the Lead Data Manager to access data quality issues and develop plans for interim analysis, DRM, DSMB etc. to key stakeholders
Drive adherence to data standards and compliance
Keep abreast of project status and ensure delivery requirements and deadlines are clear and achieved via frequent communication with project teams
Support DM team with key deliverables including documentation creation, finalization, eTMF filing, data cleaning and reconciliation, as required