Mgr Clinical Operations
Westlake Village, CA
Req ID 50466BR
Business Title
Mgr, Clinical Operations
Business
BioScience
Sub-Business
Research and Development
Country
US
State/Province
California
Location of Position
Westlake Village, CA
Shift_
1st
Job Description
•Manage both national and global clinical projects and their associated clinical teams including schedule and budget for clinical trial execution and ensuring clinical trials are conducted in accordance with Baxter clinical procedures, ICH GCP Guidelines, the Declaration of Helsinki and national regulations. •Able to work independently to manage all aspects of a clinical trial from the site selection and vendor selection process to database lock and review of the final clinical study report. Activities including product inventory management, forms development, enrollment management, timeline projections and the review of the final Clinical study report. •Coordinate all clinical trial activities while managing the interfaces with Legal, Global Project Management, Data Management, Medical Writing, Clinical Supply Chain, Clinical Compliance and Training, and Biostatistics. •Effectively manage external team/vendors activities including CRO, central lab, IRB and other external contractors. •Interact effectively with Sr. Management to provide updates and communicate issues. •Review other study documents such as protocols, Investigator's brochures, DMPs, CRFs, SAPs, and FCSR.
Job Requirements
BA/BS/Nursing or European equivalent education and/or equivalent clinical research experience prefer minimum > 5 years of clinical experience in pharmaceutical, biotechnology or medical device industry with 1-2 years project management experience. Strong knowledge base of FDA regulations and ICH GCP Guidelines. For Europe requirements, MS/MA or PhD with 1-2 years experience. For Financial Coordination, prefer some experience in Finance with emphasis in Clinical Trials/Clinical Research.
•Has working knowledge and familiarity with US Federal Food and Drug Administration, ICH/GCP, and European Regulatory Authority requirements as applicable to a study.
•Excellent verbal and written communication skills required. Interpersonal and organizational skills a must. Ability to multitask with a strong attention to detail.
•Possess working knowledge of research objectives, protocol design and data collection standards.
•Working knowledge of common office and scientific computer programs as Microsoft Word, Excel and Project
•Must demonstrate leadership skills
•Ability to travel 10% of time.
•This position is primarily sedentary work with the incumbent working in usual office working conditions with occasional walking/standing with a maximum of 30 lb. Regular attendance is required.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
