Clinical Data Specialist

East Bay, (none selected) | Contract

Post Date: 11/10/2015 Job ID: 3001 Industry: General

SCOPE OF SERVICE

 

Position Title: Clinical Data Specialist

 

Reports to: Clinical Data Manager

 

Department: Clinical

 

Original Issue Date: 10/13/2015

 

Revision Date:

 

FLSA Status: Exempt

 

 

PURPOSE OF JOB: To conduct clinical data management and database administration activities for company’s clinical studies in compliance with industry standards and applicable regulations to ensure the highest quality data

MAJOR DUTIES AND RESPONSIBILITIES:

* Perform data management and database administration activities from study startup to archival

* Establish and support clinical data management processes and standards to meet all applicable quality requirements and regulations

* Work closely with Clinical System Manager on implementation, design and maintenance of clinical and other assigned database systems

* Conduct regular data quality reviews with Clinical Operations to meet company’s goals and data management quality standards

* Develop reporting capabilities to facilitate ongoing data review and adjudication

* Participate in development and review of Data Management Plans and study-specific data instructions

* Perform other clinical data management activities, as necessary

 

EDUCATION REQUIREMENTS: Bachelor degree in life-science, statistics, mathematics or related field

 

EXPERIENCE REQUIREMENTS:

* A minimum 5 years’ industry experience in clinical data management from initiation to archival for multiple multicenter studies aiming toward FDA filing / approvals

* Experience in CDM standards for drug or devices and in implementing, validating and administrating EDC systems

* Expert knowledge of Excel

* Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials

* Understanding of industry standards, including CDISC, SDTM, CDASH

* Excellent verbal and written communication skills

* Able to complete tasks independently, accurately and efficiently with attention to detail and in a timely manner

* Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks

* Able to work with all levels and areas within the organization

 

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