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Job Title: Sr. Manager/Associate Director, Clinical Data Management (level commensurate with experience)
Description:
Serve as a subject matter expert for CDM processes and standards. Coordinate CRF design, development, and review. Coordinate Data Review Guideline (DRG) development and SAE reconciliation. Review central lab specifications; develop quality control plan, data entry guidelines; oversee coding of clinical data using MedDRA, WHO DRL, and ICD-9 as appropriate. Oversee database lock process ensuring compliance with SOPs/Guidelines, ensuring CDM Study Notebook is complete and related study documentation is filed appropriately. Develop CRO audit plan and qualification; participate in CRO selection and review of vendor Scope of Work.
Qualifications:
Thorough understanding of data management processes, including ICH and FDA guidelines. Experience with outsourcing models. Demonstrated ability to interact with and manage CROs. Ability to work in a team environment. Capable of handling multiple projects with excellent project management skills. Knowledge of database construction and EDC system.
BS or MS in biological sciences, nursing, or other medically related area. Minimum of 6-9 years of clinical data management experience working in the biotechnology or pharmaceutical industry. NDA/BLA experiences a plus.
Compensation:
Commensurate with experience
Date Posted: 11/02/2007
Email Résumé to info@cougarbiotechnology.com
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
