Data Manager-Permanent_Hybrid@Ontario,Canada
Core
Lead data management activities for clinical trials including database setup, study conduct, and close-out to ensure high-quality deliverables.
Role type
Senior Data Manager (Clinical Trials)
Builds
Clinical trial databases and data management deliverables
Domain
Clinical research / Pharmaceutical industry
Required skills
Clinical trial process knowledge, Electronic Data Capture (EDC) systems, Data Management Plan development, Query logic design, Database lock/unlock procedures, SAE reconciliation, Vendor reconciliation, Training delivery
Preferred skills
Leadership of data management teams, Prioritization in fast-paced environments, Quality drive
Technologies
Medidata Rave, Oracle InForm, OpenClinica, Medrio, Microsoft Office
Responsibilities
Lead data management activities and ensure study deliverables meet timelines and quality standards; Review clinical research documents (protocols, CRFs); Create and review eCRF specifications; Develop critical DM documents (Data Management Plan, Validation Plan, etc.); Develop edit rules, query logic, and query messages; Perform User Acceptance Testing on data entry screens and edit checks; Create and provide training to the clinical team and sites; Perform ongoing data review/reconciliation and provide metrics; Perform database lock/unlock and freeze/unfreeze activities; Coordinate archiving of study databases; Create Data Transfer Specifications and perform external vendor reconciliation; Perform SAE reconciliation.
Seniority
Senior, hands-on IC
