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Clinical Data Specialist (1825)

LanceSoft Inc, Irwindale california

Position Description
Clinical Data Specialist
Location: Irwindale, CA, must work on-site
Length: Open Ended

JOB SUMMARY
The Clinical Data Specialist will provide support to clinical trials by performing a variety of clinical research technical duties.
DUTIES & RESPONSIBILITIES
In support of Clinical Trials:
Independently ensure all study data is validated in accordance with regional and federal clinical study guidelines
Oversee database design, testing, and optimization
Create and implement clinical trial methods for collecting and analyzing site- and patient-specific clinical trial data
In support of Health Economics:
Create and maintain SOWs (contracts) and oversee invoicing
Perform literature searches and conduct outcomes research and economic modeling projects
Manage PubStrat publication management system and approval process
Support EOS copy review process including submittals for review and reference annotation process
Act as department Training Coordinator for Compliance Wire
Manage approvals for master service agreements, work proposals, and other contracts with Pharmaceutical Legal and third-party consultants
Manage Totality HCC approval process
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
QUALIFICATIONS:
BA/BS in Biology is highly preferred
Good organizational and math skills
Must be able to prioritize and make quick decisions
Knowledge of data collection practices and Medical Terminology
Knowledge of Good Research Principles
Ability to work under deadlines in a fast paced work environment
Computer literacy required in Microsoft Office such as Word, Excel and Outlook
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
Prior knowledge of electrophysiology is preferred, but not required
ADDITIONAL POSITION REQUIREMENTS
This position may require work in clinical and/or laboratory environments.
PHYSICAL WORKING CONDITIONS / REQUIREMENTS
Must be able to stand for long periods of time.
LOCATION & TRAVEL REQUIREMENTS
This position is based in Irwindale, CA
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