Clinical Affairs Manager

Organization: 
Cepheid - US
Job Location: 
Sunnyvale, CA
Job Description: 

The Clinical Affairs Manager will manage the overall operation of beta and clinical trials including project planning, budget, resource management and, if required, contract research organization management (CRO). Provides oversight, supervision, and mentorship to staff (clinical research assistant/clinical research associate).

- Manages clinical operational plan, and incorporates the study and scientific plan.
- Ensures the selection of qualified clinical trial sites.
- Develops study related documents and overall direction for the clinical sites to establish protocol development. Uses statistical analysis systems, such as SAS, as appropriate.
- Negotiates all aspects of clinical trial agreements.
- Monitors clinical trial sites for compliance and performance.
- Ensures compliance with good clinical practices (GCPs), good manufacturing practices (GMPs) and regulatory guidelines.
- Recommends and implements innovative process ideas to impact clinical trials management.
- Manages clinical budget and develops contingency plans for clinical trials.
- Oversees clinical trials staff and manages all aspects of clinical operational plan.
- Responsible for managing full scope of study, protocol and clinical report.
- Acts as a cross functional liaison to ensure study plan aligns with business development strategies.
- Selects, develops and evaluates staff to ensure the efficient support for the business function.

- Bachelor's degree in a scientific discipline or equivalent experience
- 5 to 8 years of clinical research experience within medical device (IVD preferred), biotech, or pharmaceutical
- Demonstrated management skills and the ability to develop staff
- Excellent organizational and project management skills
- Strong oral and written communication skills; strong technical writing skills
- Working knowledge of FDA regulatory requirements related to clinical research
- Travel requirements up to 20%

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