Data Management Specialist

Job Overview :

We are seeking a Data Management Specialist to join our team. In this role, you will be responsible for supporting the execution and monitoring of operational activities related to data management in clinical trials.

You will collaborate with the study team to ensure quality and compliance of data management processes, contributing to the successful conduct of clinical projects.

• Support all data management aspects of a clinical study with minimal oversight, including study start-up activities, and guide the study team through change orders and protocol amendments
• Develop DM documents, such as Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans
• Support data cleaning activities, such as study team data reviews, Non-system Edit Check Output review, SAE reconciliation and non-CRF data reconciliation
• Demonstrate collaboration and relationship-building with all study team representatives
• Manage data deliverables processes, including database locks
• Ensure data management deliverables are met on time

Required Skills and Qualifications :

Education : Degree in Engineering, Health data or similar

Languages : Fluent English, knowledge of other languages will be an asset

Experience : 2-3 years of experience in data management, extensive experience in clinical trial project data management and coordination

Specific Knowledge : Extensive knowledge of data management and tools

Personal skills : Strong communication and leadership skills, strong negotiation skills as well as excellent influencing and training / mentoring skills, ability to focus on multiple deliverables and protocols simultaneously