Clinical Trials Management System Lead (Research Institute)

Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? Right here in Montreal! At the Research Institute of the McGill University Health Centre (RI-MUHC), you can be part of an organization focused on scientific discovery and innovation in patient-centered medicine. Join us today and make a difference!

Job Description

RESEARCH INSTITUTE OF THE MUHC
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported in part by the Fonds de recherche du Québec - Santé (FRQS).

Position summary
The CTMS Transformation Lead coordinates the implementation of the CIM’s new Clinical Trial Management System (CTMS) from requirements gathering through post-deployment support. The role supports CIM teams during the transition to a modern system, contributes to process improvement, and oversees system configuration, data quality, testing, training, and adoption.
The incumbent works closely with the IT Project Manager and Finance Business Partner to ensure a successful implementation.
This is a hybrid role combining business analysis, system administration, user support, and project management.
The CTMS Transformation Lead ensures that all operational and financial processes such as study management, budget preparation, fair market value (FMV) assessment, vendor billing, coverage analysis, and account reconciliation, are well defined, correctly configured in the system, tested, and optimally used by the teams.


General Duties
Reports to: Reports to the Director of CIM (works closely with the IT Project Manager and Finance Business Partner)

Requirements Gathering (25%)
• Participate in defining CIM’s needs related to the CTMS and its integration with the ERP-Finance system for budgeting, fair market value (FMV), and coverage analysis assessment;
• Map current and future processes with research teams and subject matter experts;
• Translate operational requirements into system configuration.

System Configuration & Integration (35%)
• Configure CTMS modules according to clinical research needs and billing processes;
• Ensure workflows clearly distinguish billable costs to vendors based on FMV from standard care costs;
• Collaborate with the IT team to validate interfaces and data exchanges between the CTMS and the ERP.

Data Migration and Quality (10%)
• Support the organization and preparation of data to be migrated into the CTMS;
• Assist in verifying the quality and consistency of migrated data;
• Support the implementation of CTMS governance rules;
• Assist in the creation, analysis, and improvement of operational and financial reports.

Testing and Validation (15%)

• Participate in and execute test scenarios (, patient logs, visit billing to sponsors) and User Acceptance Testing (UAT) with users;
• Document results, follow up, and recommend adjustments as needed.
Training, SOPs & Adoption (15%)
• Develop user guides, Standard Operating Procedures (SOPs), and training modules for CIM users;
• Deliver training and support end users and super-users;
• Participate in change management, communication, and stakeholder engagement activities;
• Monitor adoption indicators and recommend continuous improvements.

STANDARDS OF PERFORMANCE

• Follows established policies and procedures;
• Exhibits excellent communication and interpersonal skills;
• Demonstrates initiative, flexibility and good judgment;
• Maintains subject expert knowledge up to date;
• Works effectively in a team;
• Confidentiality is maintained at all time;
• Prioritizes work to meet all deadlines;
• Excellent accuracy and reliability in reports and analysis produced.


SCOPE OF RESPONSIBILITIES

• Generates ideas and solutions, uses judgment to determine and execute a plan of action on assigned objectives;
• Prioritizing work in line with needs and deadlines;
• Identifying problem areas and taking appropriate action;
• Follows up with fellow team members where judged appropriate to ensure compliance, accuracy, timeliness of work submitted.

Website of the organization

Education / Experience

• Bachelor’s in science, finance, or health care professional degree;
• 5+ years of experience as a clinical research coordinator of sponsored clinical trials or equivalent in a CRO or sponsor;
• Strong knowledge of CTMS workflows, FMV, coverage analysis, and sponsored clinical trials billing practices;
• Familiarity with standard medical coding systems (diagnosis and procedure codes) for clinical trial budgeting and compliance workflows;
• Experience participating in CTMS processes;
• Excellent collaboration skills; able to represent CIM in enterprise projects;
• Bilingual (English/French) preferred.

Required Skills

• Advanced knowledge of oral and written French is required.
• An advanced knowledge of oral and written English is required, as the position requires regular and complex contact with researchers or international students who are exclusively proficient in English.