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Clinical Data Analyst II

Kelly Services


Location:
Foster City, CA
Date:
06/06/2018
2018-06-062018-07-05
Job Code:
US15TPSA_BH1439682
Categories:
  • Engineering
  • Drug Safety
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Job Details

Job Title Clinical Data Analyst II

Jobid US15TPSA_BH1439682

Location: Foster City, CA, 94404, USA

Description Clinical Data Analyst II, Foster City, CA

Responsibilities:


+ Assist members of Electronic System Compliance in providing quality and compliance oversight for the computer system validation and the electronic records / electronic signatures compliance programs
+ Conduct electronic record and electronic signature assessments and assist the business areas and IT in developing corrective action plans
+ Work to ensure that up-to-date computer system inventories and assessments of regulated systems are maintained
+ Assist with CRO/service provider audits, audits of software vendors and in-house audits, any of which may require travel
Requirements:


+ BS with 5 to 7 years of experience MS with 4 years of experience
+ Previous experience in the biotechnology / pharmaceutical or related industry implementing and validating computer systems that manage regulated information
+ Experienced in the validation of COTS and in-house developed computer systems
+ Experienced in prospective and retrospective computer system validation
+ Experienced in performing 21 CFR Part 11 and Annex 11 assessments gap analyses and developing corrective action plans
+ Knowledgeable with software development life cycles and other IT related development practices
+ Working knowledge of IT infrastructure qualification processes and IT operating procedures
+ Experienced in using, implementing, and/or validating systems, such as: drug safety, medical/drug coding, clinical trial management, clinical information, electronic data capture, electronic diary, radiological reading, laboratory information management, computerized laboratory instrumentation, document/enterprise content management, submission publishing, electronic transfer/exchange, structured product labeling, training records, CAPA, and audit tracking
+ Experienced in developing procedures for validation, electronic record and electronic signature compliance, electronic systems compliance, and/or IT operational procedures
+ Knowledgeable in 21 CFR Part 11, GCP, GLP, and GMP regulations.
**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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