| Search | |
BioFact:
(1984) The International Centre for Genetic Engineering and Biotechnology (ICGEB), the U.N. Industrial Development Organization (UNIDO) finally bows to immense political pressure from India and decides to locate the Centre in two places; India and Italy.
ATC clean room constructors...validation guaranteed!
AnorMED Inc.
Manager, Clinical Compliance
Reporting to: Director, Clinical Development
Job Summary:
Manages the definition and implementation of Clinical Compliance practices to meet GCP standards in support of regulatory filings.
Duties and Responsibilities:
- Working closely with Director, Clinical Development and Director, QA manages the development and implementation of SOP’s to meet GCP standards within the Clinical Development Group.
- Responsible for updating Clinical Staff on industry GCP Standards – ensuring staff are appropriately trained and SOP’s are updated.
- Works closely with QA to assess, draft and implement Clinical SOP’s to meet Clinical Development Priorities.
- Working Closely with Document Control, ensures that Clinical Trial Master files are up to date and meet Regulatory Standards.
- Develop system for tracking and monitoring Clinical Training.
- Manage internal Clinical compliance audits as per Standard Operating Procedures (SOPs), protocols, amendments and GCP regulations.
- Perform quality review of draft documents (e.g. protocols, informed consent forms, investigator brochure) to assure accuracy, completeness, consistency, and compliance with regulatory requirements.
- Other related duties as assigned.
Experience and Qualifications:
- B.Sc. in a scientific discipline with minimum 5 years experience developing and managing Clinical Systems or the equivalent combination of education and experience; previous experience as a CRA preferred.
- Managerial and/or Supervisory experience in Clinical Quality Assurance or in Clinical Research/Monitoring/Operations experience required.
- Strong leadership and good negotiation and diplomacy skills.
- Enhanced and up to date working knowledge of FDA GCP guidelines.
- Very thorough and has an eye for detail.
- Exceptional written, organizational, interpersonal, presentation, communication, and leadership skills.
- Manage multiple and competing priorities through effective organizational and time management skills.
- Capability to work effectively independently and as part of a team.
- Demonstrated strong ability to work with MS Office products such as Word, Excel, and PowerPoint.
AnorMED Inc. is an Equal Opportunity Employer
Submitted: 03/14/2006
