Description The
Department of Clinical Neurosciences in the
Cumming School of Medicine invites applications for a
Manager, Clinical Trials Research. This Full-time Fixed Term position is for approximately 12 months (based on length of grant funding), with the possibility of extension.
Reporting to the Senior Manager, Clinical Trials, of the Stroke Clinical Trials Group (SCTG), the Clinical Trials Research Manager plays an important role in all aspects of the clinical research process.
Summary of Key Responsibilities (job functions include but are not limited to):
Trial Management and Coordination
- Provide overall project management and hands-on coordination for all clinical trials running by the SCTG, whether the SCTG functions as a participating site, a regional/national lead, or the global sponsor/coordinating centre
- Develop and execute project plans, timelines, milestones, risk plans, and associated documentation for assigned trials to enable research objectives to be realized
- Work with individual PIs, sub-investigators, and support staff to coordinate day-to-day trial activities and resolve operational issues
- Coordinate the team to ensure that each assigned project meets its timelines, deliverables, and quality targets, and report progress to SCTG leadership against agreed milestones
- Establish and document regular meetings with PIs, clinical staff, sponsors, vendors, and external collaborators for each project assigned
Site Management
- Lead site identification, feasibility, qualification, activation, and ongoing oversight for trials sponsored or coordinated by the SCTG
- Develop and maintain site-facing operational tools, including site initiation packages, training materials, manuals of procedures, site newsletters, and site performance dashboards
- Coordinate site initiation visits, monitoring visits, and close-out activities in collaboration with the clinical research team and external CROs/monitors
- Track site enrollment, protocol deviations, and data quality metrics; escalate underperforming sites and implement corrective action plans
- Serve as primary operational point of contact for site coordinators, investigators, and pharmacy/lab staff at participating sites
Regional and Multi-Site Management
- Coordinate trial activities across regional, national, and international networks of sites, including alignment of timelines, training, and operational procedures
- Support regional leads, country leads, and partner CROs to ensure consistent trial conduct across jurisdictions
- Manage region-specific operational variations (regulatory timelines, language requirements, site agreements, drug supply logistics, ethics requirements) while maintaining protocol fidelity
- Facilitate cross-regional communication through regular operational calls, investigator meetings, and written updates
- Support international platform/master protocols (e.g., ACT-GLOBAL) including domain-specific operational planning and rollout
Data Management
- Coordinate with data management vendors and biostatisticians on CRF/eCRF design, database build, edit checks, and user acceptance testing
- Oversee data entry, query resolution, and ongoing data quality across all assigned trials, ensuring timely and accurate data capture
- Support coding activities (e.g., MedDRA, WHO-DD) and adjudication committee workflows where applicable
- Coordinate interim analyses, DSMC data cuts, and database lock activities in alignment with the protocol and statistical analysis plan
Contracts and Legal
- Submit and drive execution of clinical trial agreements, master agreements, vendor contracts, data sharing agreements, and material transfer agreements for assigned trials/project
- Work with the CSM Legal Office, CCCR, and University contracts staff to negotiate and finalize clinical trial research contracts
- Ensure that legal agreements are in compliance with negotiated financial terms, indemnification language, intellectual property provisions, and aligned with study/trial protocols
- Maintain the contracts inventory and track contract amendments, renewals, and termination obligations across the trial portfolio
Finance Management
- Develop and manage trial budgets, including per-patient costs, site payments, vendor pass-throughs, and overhead, for trials sponsored or coordinated by the SCTG
- Manage operational cash flow of assigned research projects, including procurement, accounts payable, accounts receivable, and site/vendor invoicing
- Interact with and manage trial financial operations within the UofC accounting department on a per-project basis; report to SCTG leadership on project-specific finances
- Provide quarterly and annual financial reporting to SCTG leadership and to external stakeholders, agencies, and sponsors
- Support cost-benefit analysis and forecasting to ensure that projects remain financially viable; flag variances and escalate financial risks
Regulatory Affairs and Ethics
- Responsible for, and oversee, submissions to regulatory agencies (e.g., Health Canada, FDA, EMA national competent authorities) and ethics boards (e.g., CHREB and external REBs) for trials managed by the SCTG
- Prepare and submit initial applications, protocol amendments, Investigator Brochure updates, annual reports, DSURs, SUSARs, and end-of-trial notifications within applicable timelines (e.g., Health Canada Division 5, FDA 21 CFR, EU CTR, ICH E6)
- Maintain regulatory and ethics correspondence logs and ensure timely response to agency and REB queries
- Coordinate with international regulatory leads to align submissions across jurisdictions for multi-regional trials
- Support safety reporting workflows including SAE/SUSAR review, reconciliation with the safety vendor, and timely expedited and aggregate reporting
Quality, Compliance, and Inspection Readiness
- Ensure trial conduct complies with ICH-GCP, applicable local and international regulations, sponsor requirements, institutional policies, and the approved protocol
- Lead and support inspection readiness activities, including audit/inspection scope-of-work development, mock inspections, document review, and CAPA management
- Support sponsor and regulatory audits and inspections, including responding to findings and tracking corrective and preventive actions to closure
- Implement and oversee Trial Master File (TMF) management, ensuring inspection-ready documentation and timely filing/QC of essential documents
Process and Documentation
- Develop, review, and maintain SOPs, work instructions, templates, and trial-specific manuals for the SCTG portfolio
- Standardize documentation formats, version control, and naming conventions across trials to ensure consistency and audit readiness
- Manage electronic document storage and organization in the SCTG cloud management platform; maintain each trial space within the digital management platform
- Drive continuous process improvement by identifying inefficiencies, proposing solutions, and rolling out updated processes across trial teams
Grants and Investigator Support
- Support the clinical research trials nurses, coordinators, and CRAs in the execution of clinical trials and their associated functions
- Provide support and technical expertise in the preparation of grant applications, including budget justifications, operational plans, and supporting documents
Staff Management
- Manages and supervises research staff/associates (summer students, masters, PHD, postdoctoral students and visiting fellows, other part time staff etc.)
- Manage hiring of research staff to run individual assigned tasks and projects
- Manage and coordinate part time staff involvement in completion of clinical trial/research projects
- Creates and update job profiles and manage HR process as required
- Ensure salary decisions are aligned with the AUPE Collective Agreement and project needs and budgets
- Full-scope performance management of staff, including termination when required
Qualifications / Requirements:- Masters or PhD in a health related field preferred
- 10 years experience in a health care or health research
- 5-10 years experience in clinical trial/project management and/or a proven track-record is essential
- Working towards a recognized designation preferred and supported
- Experience managing in an unionized environment an asset
- Advanced analytical, organization, planning, decision-making and financial management skills
- Excellent oral and written communication and interpersonal skills, combined with excellent customer service and demonstrated leadership abilities
- Must demonstrate excellent problem solving, critical thinking, and innovative skills
- Must demonstrate efficient organizational and time management skills in setting appropriate priorities and accomplishing tasks within deadlines
- Ability to build effective relationships through a high level of cooperation and understanding when dealing within the University or outside the University
- Knowledge of the University, the Cumming School of Medicine and departmental policies, regulations and procedures pertaining to financial matters
- Demonstrated experience in developing policies and procedures
- Adapt to changes in organizational structures, systems and policies
- Strong team work as well as time management skills are required
- Knowledge of university core business systems and an excellent working knowledge of Microsoft Office applications
- Strong understanding of financial management principles is required
- Previous experience working with University of Calgary applications and systems required (PeopleSoft, EFin, IRISS, Raisers Edge, Enterprise Reporting)
Application Deadline: August 31, 2026
We would like to thank all applicants in advance for submitting their resumes. Please note, only those candidates chosen to continue on through the selection process will be contacted.
This position is classified in the
Management Career Band, Level 1 of the Management and Professional Staff Career Framework.
For a listing of all management and staff opportunities at the University of Calgary, view our
Management and Staff Careers website .
