Project Support
Assist in essential IRT documentation preparation for various trial stages (i.e., start-up, maintenance)
Draft IRT-related documents using standard templates, including IRT User Guides and test scripts
Assist in basic database testing activities to ensure system functionality and accuracy
Support User Acceptance Testing (UAT) efforts in collaboration with cross-functional teams
Provide support for trial drug inventory management and ordering as needed
Assist in the generation of report requests and review report outputs for accuracy and relevance
Assist with the creation and delivery of Data Transfers in accordance with study requirements
Ensure approved study documentation is maintained and properly stored in the electronic Trial Master File (eTMF)
Perform administrative tasks on assigned trials, including document and report distribution, internal communications, and eTMF submissions
Support the scheduling and coordination of client and internal meetings
Provide user support to internal team members and customers
Troubleshoot, triage, or escalating issues when needed
Demonstrate solid understanding of IRT systems, processes, and best practices
Department Support
Contribute to the continuous improvement of IRT, Data Management, and the broader organization through active knowledge sharing, training, and educational initiatives
Serve as an internal and external advocate for IRT, promoting its value and best practices across teams and stakeholders
May participate in and/or lead CDM and cross-functional working groups
Qualifications
The successful candidate will posses a post secondary diploma/certificate with a minimum of 1-3 years related experience.
Must be fluent in the reading, writing and speaking of English
Basic understanding of clinical trial processes and protocols, especially relating to subject randomization, drug supply logistics, and data collection within IRT systems.
Knowledge of GxP, ICH-GCP, and regulatory requirements to ensure IRT compliance in clinical trials conducted in multiple regions.
Experience collaborating cross-functionally with clinical operations, data management, supply chain, biostatistics, and sponsor teams to align IRT functionality with study requirements.
Proficiency in managing IRT system documentation, such as User Requirements Specifications (URS), User Acceptance Testing (UAT) scripts, and validation records.
Strong project coordination skills, including timeline management, issue tracking, and vendor oversight, to support global clinical studies effectively.
Excellent communication skills, both written and verbal, facilitate effective collaboration with internal teams, sponsors, and IRT vendors across different time zones.
Working knowledge of clinical trial processes, including basic familiarity with randomization procedures, IP labeling and packaging workflows, distribution coordination, and routine supply tracking. Supports the management of unblinded study information under appropriate supervision. Foundational experience with IRT systems, including performing routine data entry, running standard reports, and assisting with system updates as directed.
