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Clinical Trial Manager/Sr. CTM

Astex Pharmaceuticals, Inc.

Location:
Dublin, CA
Posted Date:
7/10/2014
Position Type:
Full time
Job Code:
14-22R
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Cancer, Clinical Operations, Clinical Trial, Clinical Trial Manager, Oncology, Pharmaceutical,

Job Description

Work for a company that is making a difference in the fight against cancer. Astex Pharmaceuticals, Inc., www.astx.com, brings together high tech and biotech to discover and develop more effective medicines for the treatment of cancer. We are looking for a motivated, dedicated professional who wants to combine their skills with our uniquely talented team to change the current paradigm of drug discovery and development. This position is based in our Corporate Office located in Dublin, California, just a 10-minute shuttle ride from the Dublin-Pleasanton BART station.

As a Clinical Trial Manager you will be responsible for and/or assisting with the execution of Investigator-Sponsored Trials and Astex-sponsored hematological clinical trials from protocol concept through clinical study report.

Responsibilities:

•   Coordinate with investigators and investigator sites related to Investigator-Sponsored Studies and Astex-sponsored studies to ensure timely start-up and efficient processes
•   Coordinate and/or participate in investigator meetings
•   Participate in forecasting Investigator Medicinal Product needs and other clinical supplies
•   Execute high-quality, integrated, cross-functional plans for assigned clinical trials by coordinating day-to-day activities with functional groups in the clinical study team both internal and external to Astex
•   Assist in planning and execution of clinical projects while adhering to budget, scope, and timeline requirements.
•   Apply best practices in the development, initiation, planning, execution, control, and closing of clinical trials
•   Ensure studies are carried out according to ICH/GCP regulations
•   Participate in site selection and site management from start-up through close-out
•   Work closely with vendors for Astex-sponsored clinical trials
•   Assist with training vendors/CRAs related to study activities
•   May interact with others in research and development including data management, drug safety, manufacturing, regulatory, and quality functional groups
•   While this role does not have direct reports, it partners closely with clinical study manager and clinical project assistant

Requirements

Requirements:

•   Minimum education: Bachelors degree
•   Minimum relevant experience: 4-5 years of clinical trial management
•   Hem-onc Investigator-Sponsored Studies experience desired
•   Anticipated travel: Up to 20%
•   Advanced proficiency with MS Word and Excel
•   Proven ability to work independently with minimal direction/supervision
•   Exceptional communication skills

Astex Pharmaceuticals is an Equal Opportunity Employer

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