Clinical Trial Systems Lead, Calgary Centre for Clinical Research

Clinical Trial Systems Lead, Calgary Centre for Clinical Research

08 Nov
|
University of Calgary
|
Calgary

08 Nov

University of Calgary

Calgary

Description

The Calgary Centre for Clinical Research in the Cumming School of Medicine invites applications for a Clinical Trial Systems Lead. This Full-time Fixed Termposition is for approximately 12 months (based on length of grant funding), with the possibility of extension.

Under the guidance of the Manager, Clinical Trial System Services the Clinical Trial Systems Lead focuses on technical coordination and administration of the province’s Clinical Trial Management System, (OnCore), the Electronic Regulatory System (eReg) and multiple system integrations for the Provincial Clinical Trial Management (CTM) and Regulatory Systems Consortium member institutions. The role is primarily responsible for liaising with provincial partners, institution’s integration leads, and software vendor to coordinate system upgrades, solve complex issues using analytical thinking, and bring new perspective on existing solutions. This position also supports the Provincial Consortium through duties including data requests, exploring current or optimal system functionality and ad hoc requests.

Reporting to the Manager, Clinical Trial Systems Services, the Clinical Trial Systems Lead is a key member of a Provincial OnCore Support Team (POST) within the Calgary Centre for Clinical Research in the Cumming School of Medicine. It will require normal work hours with occasional evening or weekend hours during peak times.

Summary of Key Responsibilities

Clinical Trial Management and Electronic Regulatory System and Integration Support

- Responsible for coordinating technical activities related to the clinical trial management system, including upgrades, integrations, testing, and issue resolution across multiple organization




- Leads the planning and coordination of system upgrades and optimizations
- Leads test and release processes by writing and running test scripts for OnCore and eReg system upgrades with a deep understanding of related integrations and the impact of errors
- Coordinate technical teams across multiple organizations
- Review vendor release notes
- Understand how changes may affect system integrations and impact end user experiences
- Ensure IT teams assess and test impacts
- Coordinate technical testing and remediation activities
- Translate user and workflow requirements to technical teams
- Translate technical changes into operational impacts for users
- Supports POST by doing QA reviews of clinical trial documents from study teams or University systems
- Provides OnCore technical support and is a subject matter expert in protocol management, subject administration and financial management
- Maintains knowledge of ongoing research projects and study teams in OnCore
- Identifies and performs data blitzes to bring all protocols to the same data quality standard
- Provides tier 3 support for resolving complex OnCore builds, financial issues and other system issues

Training/Documentation

- Writes job aids for OnCore tasks using technical writing templates and POST style guide




- Assists with the planning and delivery of OnCore training via D2L, desire2learn
- Updates training modules for OnCore and eReg as needed
- Records user training completion and onboards successful users to OnCore and eReg user environments
- Participates in the planning and delivery of monthly Coordinator Community of Practice events, including providing one‑on‑one user support in a group setting
- Leads individual end user support sessions and resolves complex financial and technical issues as needed
- Provides guidance, mentorship, and advice to team members

Communication/Relationships

- Shares responsibility for a central inbox, communicating daily with study teams and University departments
- Exercises a high degree of confidentiality, tact, diplomacy and good judgement when dealing with external and internal stakeholders during stressful and busy periods of work
- Follows and develops standard operating procedures and established practices for main responsibilities
- Identifies deficiencies and areas for improvement in POST documentation
- Utilizes various digital tools, such as multiple SharePoint tracking lists, MS Teams chat, Microsoft
- Planner, and MS Teams hub
- Demonstrates leadership in developing new projects to enhance team operations, user success
- Exchanges complex information, asks questions, and checks for understanding with teammates and study teams
- Build relationships with teammates, staff within immediate faculty/department/unit and across the universities supported by team
- Develops relationships with consortium member representatives, Advarra and key system integration support contacts to proactive

📌 Clinical Trial Systems Lead, Calgary Centre for Clinical Research
🏢 University of Calgary
📍 Calgary

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