24 Aug
|
Puzzle Medical Devices
|
Montreal
24 Aug
Puzzle Medical Devices
Montreal
Puzzle Medical Devices is seeking a Senior Clinical Data Manager to join the Clinical team. This role owns clinical data management activities across the company's clinical studies, including electronic data capture (EDC) system setup and administration, case report form (CRF) design support, data cleaning and quality control, and the preparation of data listings, summaries, and reports for internal stakeholders and regulatory submissions. Responsibilities Clinical Data Management & EDC Lead end-to-end clinical data management for assigned studies, from database build through database lock, in accordance with the study's Data Management Plan (DMP). Build, configure, test, and maintain the Electronic Data Capture (EDC) system, including edit checks, user access,
and version control across study amendments. Own the accuracy, completeness, and timeliness of data entered into the EDC across all active studies. Develop and maintain data validation rules, run data quality checks, and manage query resolution with clinical sites. Perform data reconciliation across source systems (e.G., EDC, safety database, central lab) and support responsible adverse event (SAE) reconciliation. Draft and maintain data management documentation, including the DMP, CRF completion guidelines, and data
📌 Clinical Specialist (Montreal)
🏢 Puzzle Medical Devices
📍 Montreal