The Clinical Project Manager will be responsible for managing the company's clinical trial activities as a member of the clinical department. This is a contract position until the end of 2010, with the possibility of renewal/extension to a permanent position thereafter.

Responsibilities:

• Responsible for overseeing the implementation fo all activities related to assigned clinical trials.
• Acts as a primary point of contact for contract research organizations.
• Works well with all relevant groups (internal and external) to ensure all activities are managed appropriately.
• Responsible for preparation of requests for proposals, evaluation and selection of investigators, study sites, CROs, and other service providers.
• Responsible for the preparation of clinical trial budget and tracking and managing expenditures.
• Actively participates in all aspects of project development, including assisting in drafting, review and finalization of clinical study protocols, ICFs, CRFs, study plans, reports, and other regulatory documents.
• Assists legal department in preparation of contracts with timelines, budgets and deliverables."
• Monitor and manage clinical trial timelines and provide regular progress reports to senior management.
• Oversees adherence to recognized guidelines, clinical trial protocol and standards of clinical practice.
• Works within team environment and interacts with other clinical colleagues.
• Develops and updates SOPs as required.
• Reports to the Associate Director of Clinical Operations.

Knowledge & Education Requirements:

• A Bachelor degree in a relevant discipline, or RN.
• 4+ years experience managing clinical trials within the biotech/pharmaceutical industry or 5+ years of clinical project/study management experience at a clinical research organization, preferably in pain clinical trials.
• An excellent understanding of the clinical research process from design to reporting.
• Demonstrated ability to successfully manage and complete Phase 2 proof of concept trials on time and on budget.
• Excellent knowledge of ICH/GCP Guidelines.
• Strong knowledge of US and Canadian regulatory environments with previous experience with CTA and IND submissions and regulatory experience with global clinical trials preferred.
• Excellent oral and written communication and inter-personal skills.
• Strong teamwork and collaborative approach.
• Attention to detail and a proven track record of problem solving.

Please submit your CV and a cover letter to careers@xenon-pharma.com.