Senior Clinical Data Manager - Pleasanton, CA | Biospace
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Senior Clinical Data Manager

Astex Pharmaceuticals, Inc.

Location:
Pleasanton, CA
Posted Date:
2/6/2017
Position Type:
Full time
Job Code:
16-32R
Salary:
Competitive: DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Cancer, Clinical Data Management, Manager, Oncology,

Job Description

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 Senior Clinical Data Manager will be responsible for leading and conducting data management activities for Astex’s clinical trials from start up to close out. This position works closely with internal development colleagues and external clients to ensure delivery to time, quality, and cost expectations, and performs day-to-day data management activities according to ICH guidelines, regulatory requirements, and the company’s standard operating procedures.

Responsibilities:
•   Ensure that management’s clinical development objectives are met with regards to Data Management activities
•   Provide operational leadership to the direction, planning, execution, collection, and interpretation of all clinical data to the highest quality standards
•   Report status of clinical data management activities to project teams and management
•   Assist with data preparation for reporting clinical study results for regulatory filings, publications, presentations
•   Conduct clinical data management activities using Electronic Data Capture (EDC) systems such as OmniComm’s Trial Master, Medidata Rave, and/or InForm
•   Assist with developing and implementing data management standard operating procedures
•   Assist with creating written data management plans
•   Design database structures and case report forms consistent with CDISC and CDASH initiatives
•   Work with third-party vendors to develop data transfer specifications
•   Mentor junior data management personnel and CRO/internal staff as appropriate
•   Provide assistance with troubleshooting and correcting database issues

Requirements

Requirements:
•   Minimum education: BS in life sciences or related field
•   Minimum experience: 6 years managing clinical trial data in a pharmaceutical, biotech, or CRO setting; oncology trial experience strongly preferred
•   Advanced proficiency in core data management activities (e.g., case report form design, data edit specifications and data validation, creation of data management plans, expert use of adverse events and concomitant medication coding dictionaries, attention to detail and data quality)
•   Strong track record of leading clinical data management activities; early and late stage, and submission experience are highly desirable
•   Proficiency using data management systems such as OmniComm’s Trial Master, Medidata Rave, and/or InForm
•   Proficiency with database development and programming languages such as SAS is highly desirable but not required
•   Knowledge of CDISC standards for CDASH and SDTM is a plus
•   Proficiency using Microsoft Word, Excel, and PowerPoint
•   Exceptional communication (oral and written) and interpersonal/team skills