AnorMED Inc.
Clinical Trials Manager
Reporting to: Director, Clinical Operations
Job Summary:
Under the direction of the Director, Clinical Operations, manages day to day activities related to the conduct of clinical trials.
Duties and Responsibilities:
- Oversees issues related to the day to day conduct of clinical trials including reviewing case report forms, secondary monitoring of clinical trials, and review of data listings.
- Ensures all clinical study results are properly evaluated, monitored and documented.
- Assists in selecting Clinical Research Organizations as well as study sites.
- Develops budgets for clinical trials as well as assisting in developing clinical trial agreements with investigator sites.
- Reviews and writes clinical updates as required for IND annual reports.
- Oversees and approves requests from CRO’s for modifications to procedures requests.
- Acts as a mentor and directs the lead CRAs and/or CRAs assigned to the study.
- Provides back up support to CRAs for day to day contact with study sites to ensure data quality and compliance with study protocols.
- Takes part in protocol design and amendment recommendations for clinical trials and reviews all trial related documents.
- Ensures GCP compliance is maintained.
- Ensures clinical trials are conducted according to schedule and budget.
- Other related duties as required.
Experience and Qualifications:
- BSc in a related discipline and a minimum of 5 years industry experience in the conduct of clinical trials, or the equivalent combination of education and experience.
- Excellent communication skills, both verbal and written.
- The ability to develop relationships and interact with staff at all levels of the organization.
- Experience in Phase III clinical study management and participation in NDA completion an asset.
We encourage all applicants to apply online at www.anormed.com under the 'Careers' section.
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AnorMED Inc.
AnorMED Inc. is an Equal Opportunity Employer
Submitted: 02/28/2006