Clinical Trials Project Manager

**Classification & Regular Hours**:

- Hours per Week: 35
- Salary Grade 14: $65,050 - $76,550, commensurate with experience.
- Please note, this is a wholly grant funded, 1 year temporary full time contract opportunity with a benefits package.

** About Western**:

- **About Us**:

- The Department of Paediatrics encourages and develops innovative research in a collaborative setting focusing on child health. Our undergraduate and postgraduate education programs enrich the student experience to provide the knowledge and skills needed to ensure exemplary care across multidisciplinary paediatric sub-specialties. Exceptional specialized clinical care is provided to children in Southwestern Ontario from faculty committed to child health.

** Responsibilities**:

- The Clinical Trials Project Manager will be responsible for implementing and managing multi-country clinical trials aimed at repurposing drug(s) for the treatment of Long-COVID and related research initiatives. The role will coordinate a new phase IV clinical trial examining the use of already approved repurposed drugs to evaluate the efficacy and safety of one or more drug(s) in alleviating symptoms and improving quality of life in patients with Long-COVID. The Clinical Trials Project Manager will also assist in gathering data as well as clinical assessments which will include symptom scores, quality of life measures, and biomarker collection at regular intervals. The role will be a primary point of contact for internal and external inquiries related to all aspects of the clinical trial and will coordinate and oversee the logístical and day-to-day activities of the clinical trial conduct. The role will also work in close liaison with other study members, draft manuscripts, plan methodologies along with the Principal Investigator, and perform literature reviews.
- In addition to these responsibilities, the Clinical Trials Project Manager provides leadership in global regulatory submissions (Health Canada, FDA, EMA, and other jurisdictions), international trial startup, and oversight of site operations, investigational product supply, and vendor contracts. The role ensures adherence to Good Clinical Practice (GCP), institutional SOPs, and international regulatory requirements while managing budgets, resources, and timelines. The Project Manager develops training programs and supervises global site staff to ensure compliance, data quality, and patient safety, and serves as the primary liaison for cross-functional teams, CROs, and international sites. By combining operational management with scientific development, the role is accountable for ensuring that complex multi-country trials are executed efficiently, ethically, and with high scientific integrity.

** Qualifications**:

- Education:

- Undergraduate Degree in Life Sciences and a Diploma in Clinical Trials Management
- Biomedical Research Ethics and Tri-Council Policy Statement training
- Clinical Research Coordinator Professional Certification (CRCPC) is preferred
- Lawson Health Science research qualifications considered an asset (GCP, SOP modules, etc.)- Experience:

- 5 years of experience managing clinical trials in an academic research environment
- Experience with clinical drug trials and knowledge of GCP and regulatory requirements
- Experience in clinical trial proposal writing preferred
- Experience preparing scientific presentations (oral and poster format) would be an asset
- Experience with building and maintaining REDCap databases is preferred- Knowledge, Skills & Abilities:

- Knowledge of regulations and guidelines governing research ethics in an academic environment, and with Western’s Ethics procedures preferred
- Proven project management skills to manage multiple projects simultaneously from conception to completion within prescribed timeline
- Ability to investigate defined issues, solicit input, and suggest remedies and alternative approaches that meet the needs of the situation
- Ability to ensure confidentiality and privacy is maintained through the appropriate retention and destruction of information
- Communication skills to listen to the complete message, solicit more information as required, and give feedback on the message received
- Verbal communication skills to clearly express ideas in an objective manner, and adapt communication style to suit the situation and audience
- Communication skills with an ability to complete detailed analytics and report
- Communication skills to describe research processes effectively to a lay and academic audience
- Demonstrated effective organizational skills involving time management and prioritization
- Demonstrated ability to work independently with mínimal supervision as well as part of an interdisciplinary team
- Demonstrated flexibility, adaptability, and ability to manage change in dynamic environment
- Professional manner, tact, diplomacy and discretion in dealing with associated and colleagues including senior management
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