Clinical Systems Coordinator Belgium
The Clinical Systems Manager/Coordinator is responsible for managing the set-up, implementation, design and maintenance, development and security of various clinical information systems including but not limited to Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and electronic Data Capture (EDC) systems, Electronic Health Record (EHR) among others.
- Develops, maintains, and oversees applicable SOPs and templates to ensure that routine clinical systems operations are performed in adherence with ICH/GCP/regulatory guidelines and established best practices
- Develops and designs a compliant GxP in-house clinical system applications and tools.
- Manages projects to ensure effective integration of clinical systems as appropriate.
- In collaboration with other company stakeholders, creates and implements policies related to data and cybersecurity across the organization.
- Supports Clinical Operations, Data management and Site-Support teams with study set up, maintenance of (clinical) systems.
- Leads and/or participates in the new clinical systems operations initiatives to help streamline and standardize processes.
- Leads user training (internal and external) and train-the-trainer training sessions, establishing, and maintaining user reference materials for all user types and tracking trained users, user access and CTMS permissions.
- Acts as an administrator in the applicable clinical systems.
- Liaise with different system vendors for system updates and technical inquiries.
- May participate in activities related to building study databases and applies advanced knowledge in the programming of complex CRF design, database building, edit checks, intermediate to complicated reports, custom programming, system interfaces and all system feature configurations.
Bachelor or master’s in computer science, software or application development or other IT related course.
Proven experience in software and application development.
Working knowledge of clinical trial operations and/or clinical data management
Strong background of 21 CFR part 11 and GAMP5 is desirable
With good communication and interpersonal skills.
Agile and with Can-Do attitude
Clinitude… It’s all about attitude!
Submit your resume and motivation to firstname.lastname@example.org.