Data Manager(Inhouse)_Hybrid@Ontario,Canada
Core
Leading data management activities for clinical trials including database setup, study conduct, and close-out to ensure high-quality deliverables.
Role type
Data Manager (Clinical Trials)
Builds
Clinical trial databases and data management deliverables
Domain
Clinical research / Pharmaceutical industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data management planning, eCRF specification, edit rule development, data validation, database lock/unlock, SAE reconciliation, clinical trial process knowledge, GCP/ICH compliance, Medidata Rave, Oracle InForm, OpenClinica, Medrio
Preferred skills
Team leadership, training delivery, quality improvement, timeline management
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
Mid-level, hands-on IC