Astellas Pharma Canada is currently searching for a Principal Clinical Research Associate for our Clinical Research group. Reporting to Linda Taylor, Manager, Clinical Projects, Research & Development, the successful candidate will be responsible for but not limited to:

Managing the overall implementation, conduct, and completion of multiple clinical trials from Phase 2 to Phase 4, ensuring that forecasted timelines, budgets and study performance objectives are achieved. Forecasts clinical drug supplies and negotiates study site and contract research organisation budgets.

Leading large multidisciplinary project teams consisting of in-house and external R&D members, CRO Project Leaders, professional consultants, and others.

Collaborates with R&D staff in the development of clinical study protocols, CRFs, clinical study reports and other clinical documents. Reviews safety reports, monitoring reports, status reports etc.

Ensures that sites comply with Health Canada and/or FDA regulations; meet Tri-Council ICH/GCP guideline standards, and adhere to PIPEDA and other applicable privacy legislation.

The key skills and experience required include:

B.Sc/B.A in life sciences or RN degree or M.Sc. degree with three years or more experience clinical research project management in the ethical pharmaceutical industry.

Demonstrated ability to effectively manage large multidisciplinary Project Teams.

Excellent interpersonal skills, written and verbal communication skills, administrative skills and computer ability (proficiency in Microsoft Office applications required; proficiency in Microsoft Project desired).

Working knowledge of clinical study protocol development and implementation, all aspects of the clinical trial process, and familiarity with the clinical drug development process, including relevant Canadian guidelines and regulations.

Moderate (30-50%) travel required.

Bilingual (English/French) an asset

If you are interested in applying for this position, or you are aware of any candidates who may possess the attributes for this opportunity, please contact Vicki Rickard at extension 5614. Please refer to the employee handbook, pages 12 & 13 regarding application procedures and the referral program.