Clinical Trial Project Lead - Tech 6 (AESES)

George & Fay Yee Ctr. Healthcare Innov., Vice-Dean Research

Rady Faculty of Health Sciences

Position number: 37700

Date posted: April 17, 2026

Job details

Clinical Trial Project Lead - Tech 6 (AESES)

New Project Full-Time (Budget Funded)

Full-time:

Yes

Permanent:

No

Work schedule:

35 Hours/week (Monday to Friday, 8:00 am to 4:00 pm)

Salary:

$32.15 to $46.36 per hour ($58,513.00 to $84,375.20 per annum)

Appointment Dates

May 25, 2026 to December 22, 2027

Trial/Probation period:

840 hours worked

For more information please contact: Andrea Toyne - andrea.toyne@umanitoba.ca

Qualifications

MINIMUM FORMAL EDUCATION/TRAINING REQUIRED:

• PhD in related study area with three years = directly-related experience.

OR

• Masters degree in related study area with five years = directly-related experience.

OR

• Bachelors degree in related study area with seven years = related experience.

EXPERIENCE: .

• Experience in coordinating and managing clinical trials and knowledge of research protocols and regulatory documentation required.
• Experience working on interventional drug studies required.
• Experience working in a multidisciplinary research team is required.
• Experience with Electronic Data Capture software required.
• Working knowledge of Good Clinical Practice and Health Canada guidelines, PHIA and Tri-Council Policy Statement on Research is required.
• Experience in the management and/or supervision of a team including oversight of daily operations, task delegation and performance evaluations.
• Experience in the coordination and management of clinical trials including and not limited to protocol review, regulatory responsibilities, site selection, contracts, budgets, site initiation, site payments, recruitment, site engagement, problem solving, monitoring, grant funding.
• Experience with research ethics boards submissions, including initial submissions, amendments, annual approvals, adverse events and protocol deviation reporting, etc.
• Experience with managing finances, such as budgets, invoicing, reimbursements, etc.
• Experience in training new staff and conducting performance evaluations.
• Experience creating data capture forms and other study related materials preferred.
• An acceptable equivalent combination of education and experience may be considered.

SKILLS AND ABILITIES:

• Demonstrated excellent interpersonal and communication skills in English are required.
• Knowledge of clinical trials is required.
• Ability to plan, organize and administer projects is required.
• Ability to work both independently and as part of a multidisciplinary team is required.
• Demonstrated time management skills and the ability to multi-task are required.
• Knowledge of computer software and proficient use of Microsoft Office including Teams, Outlook, PowerPoint, andExcel is required.
• Satisfactory clearance of criminal records check is required.
• A satisfactory work record, including satisfactory attendance and punctuality, is required.

OTHER JOB RELATED QUALIFICATIONS:

• Bilingual in French and English (written and oral) is preferred.
• Knowledge of online databases (such as REDCap and Spinnaker) is desired.

Key responsibilities

Responsibilities

• Aids in the management and oversight of clinical research studies such as drug and investigational procedure studies for national and international sites.
• Develops study related materials such as consent forms, protocols, study manuals, case report forms, lab manuals and other study-related materials for the study Sponsor or Sponsor/Investigator.
• Collaborate with the Data Coordinating Centre for the development and ongoing management of the Electronic Data Capture system.
• Completes RITHIM/HARMONY, CanReview and Health Canada applications and coordinates site submissions.
• Collects and submits participating sites’ required documents to Regulatory Authorities such as Health Canada and the FDA including but not limited to the Qualified Investigator Undertaking (QIU) Form, Clinical Trial Site information form (CTSI), Statement of Investigator form 1572, and other required documents.
• Ensures compliance with ICH-GCP, Tri-council (TCPS2), FIPPA/PHIA, Health Canada Division 5 and other regulatory requirements and related institutional policies in the conduct of clinical studies.
• Manages and ensures participating sites are maintaining study regulatory documents, including monitoring data, screening logs, enrolment logs, and verifying source data.
• Coordinates various bi-weekly meetings, aids in the preparation and circulation of meeting agendas, presentations, progress reports, results and meeting minutes.
• Submits annual study status and DSMB reports to local ethics boards and ensures appropriate participating site submissions.
• Oversees safety reporting and management across all domains, ensuring appropriate cross-domain safety signal detection.
• Liaises with the various departments to facilitate interaction and communications between the appropriate individuals and other departments to support research activities.
• Aids researchers with grant application processes including identifying funding opportunities and working with investigators to prepare grant applications and study budgets.
• Manages grant budgets for local, national and international research projects.
• Collaborates with Finance (eg: Supply Payment Services) and Admin to secure required project funding and approves/tracks expenditures incurred.
• Collaborate with the Office of Research Services in the creation and execution of research contracts (clinical trial agreements, service agreements).
• Maintains a trial master file and study filing system as needed.
• Develop presentations and presents information and training sessions to project team or sites.
• Establishes and leads patient advisory committees, facilitating meetings and communications to integrate meaningful patient perspectives into all aspects of trial design.
• Provides general back up support and training to other team members when required.
• Provides training to new research staff and sites on study protocols, ethics and day-to-day research activities.
• Assist in problem solving, answering questions, and supporting research staff.
• Assists with other related projects and duties as assigned.
• Aids researchers with grant application processes including identifying funding opportunities and working with investigators to prepare grant applications and study budgets.
• Manages grant budgets for local, national and international research projects.
• Collaborates with Finance (eg: Supply Payment Services) and Admin to secure required project funding and approves/tracks expenditures incurred.
• Collaborate with the Office of Research Services in the creation and execution of research contracts (clinical trial agreements, service agreements, etc.).
• Provides general back up support to other team members when required.
• Provides training to new research staff in study protocols, ethics and day-to-day research activities.
• Assist in problem solving, answering questions, and supporting research staff.

LOCAL RESEARCH PROJECTS/CHIRON TEAM MANAGEMENT (CLINICAL OPERATIONS)

• Directs the coordination and oversight of clinical research studies being conducted at local participating sites.
• Oversees the completion of local RITHIM and coordination of contracts, annual study status and DSMB reports to local ethics boards.
• Ensures team training of ICH-GCP, Tri-council (TCPS2), FIPPA/PHIA, Health Canada Division 5 and other regulatory requirements and related institutional policies in the conduct of clinical studies.
• Ensures our local participating sites are maintaining study regulatory documents, including monitoring of data, screening logs, enrolment logs, and verifying source data.
• Coordinates meetings, aids in the preparation and circulation of meeting agendas, presentations, progress reports, results and meeting minutes.
• Liaises with study sponsors and various departments to facilitate interaction and communications to support research activities (University of Manitoba Departments – ORS, RITHIM, hospital services) including finance.
• Maintains financial oversight of site budgets including accounts, expenses, invoices and payments.
• Maintains a study filing system as needed.
• Develops presentations and presents information and training sessions as needed.
• Assumes a leadership role in promoting and maintaining an effective team approach to local recruitment strategies and trials.
• Provides training to new research staff in study protocols, ethics and day-to-day research activities
• Assists in problem solving, answering questions, and supporting research staff.
• Creates an environment that encourages and supports creativity, innovation, critical thinking and a healthy workplace environment..
• Accepts responsibility for appropriate delegation, monitoring, and evaluation of delegated activities.
• Promotes good interpersonal relationships by modelling professional behavior and practices.
• Conducts regular meetings with research teams to facilitate two-way communication of information, issues and challenges
• Provides general back up support to other team members when required.
• May be required to perform related duties not exceeding skills and capabilities as required.

Additional information

The University of Manitoba is committed to the principles of equity, diversity & inclusion and to promoting opportunities in hiring, promotion and tenure (where applicable) for systemically marginalized groups who have been excluded from full participation at the University and the larger community including Indigenous Peoples, women, racialized persons, persons with disabilities and those who identify as 2SLGBTQIA+ (Two Spirit, lesbian, gay, bisexual, trans, questioning, intersex, asexual and other diverse sexual identities).

If you require accommodation supports during the recruitment process, please contact UM.Accommodation@umanitoba.ca or 204-474-7195. Please note this contact information is for accommodation reasons only.

Application materials, including letters of reference, will be handled in accordance with the protection of privacy provisions of "The Freedom of Information and Protection of Privacy Act" (Manitoba). Please note that curriculum vitae will be provided to participating members of the search process.