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.
AnorMED Inc.
AnorMED Inc. is an Equal Opportunity Employer
Submitted: 02/28/2006