Clinical Trial Manager

Location
Pleasanton, CA
Posted
Oct 17, 2018
Required Education
Bachelors Degree
Position Type
Full time

Join a company that’s making a difference in the fight against cancer. Astex Pharmaceuticals, www.astx.com, is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. We are looking for an experienced and motivated professional interested in applying their unique skills to our shared mission. This position will be based in our office located in Pleasanton, California near the Dublin-Pleasanton BART station in the Rosewood Commons campus: http://www.rosewoodcommons.com/transformation.html

The Clinical Trial Manager partners with the Astex Clinical Operations staff and other departments to ensure that Astex clinical trials are conducted in accordance with corporate Standard Operating Procedures (SOPs) and Guidelines, Good Clinical Practices (GCP), ICH Guidelines and applicable federal and national regulations (FDA and EMEA). This role can be either contract or direct hire.

• Manage studies within a program with minimal supervision
• Assist in the preparation of safety, interim, and final study reports
• Assist in site selection, study implementation and ongoing management of study sites either directly or via service providers 
• Participate in forecasting study drug supply requirements and managing logistics
• Manage and maintain CRO/service provider relationships
• Coordinate and/or participate in Investigator meetings
• Train study coordinators and investigators on Good Clinical Practice/ICH and Astex processes
• Participate in the development of best practices for Phase 1-3 study management
• Determine methods and procedures on new assignments with minimal supervision
• Travel: Up to 25%
 

• BA/BS in a relevant scientific discipline 
• Minimum 2-5 years’ related clinical trial management experience in the pharmaceutical industry or equivalent; oncology experience is highly desirable
• Exceptional oral, written, interpersonal, and presentation skills 
• Proficiency using Microsoft Office
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
• Ability to prioritize multiple tasks, plan proactively, and accomplish goals within timelines
• Ability to develop tools and processes that increase measured efficiencies of the project
• Strong attention to detail and meticulous follow-through in a fast-paced environment