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Data Management Specialist 1

Charles River Laboratories International Inc (CRL)

Reno, NV, US, 89511

Data Management Specialist 1 Req ID #:  192813 Location: 

Reno, NV, US, 89511 For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about. Job Qualifications

BASIC SUMMARY: 

Independently support data tabulation and electronic data submissions, including the use or 

maintenance of data tools, automations, laboratory software, and business applications to ensure 

quality and adherence to the GLPs, GCPs, SOPs, and site policy.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Tabulate study data under the guidance of the Study Director or Scientist to create an accurate 

representation of data as indicated by protocol and amendments.

• Support SEND study data submissions requirements.

• Conduct tabulation and statistical analyses of specialty data. 

• Prepare responses to quality assurance audits.

• Conduct peer review of tabulation as needed within the Data Management department.

• Proficient in all skills related to secondary review, raw data correction, and tabulation of nonspecialty study data.

• Assist in mentoring and training of junior roles within the Data Management group. 

• Assist in creating, maintaining, and updating departmental procedures and templates.

• Coordinate with Sponsors and their data vendors in support of appropriate data transfers to 

external parties, including the drafting and execution of Data Transfer Agreements.

• Utilize macros in support of data quality or data reduction activities.

• Prepare data files of moderate complexity in accordance to the Data Transfer Agreement.

• Provide support to senior Data Specialists in projects involving new software, business 

applications, or automations that impact data outputs or presentation.

• Handle special, rush and high priority jobs as assigned by Study Directors, Scientist, and/or 

Supervisor.

• May support CLIA pre and post analytical activities.

• Perform other related duties as assigned by supervisor.

  Job Summary

QUALIFICATIONS:

• Education: Bachelor’s degree (B.S./B.A.) or equivalent experience preferred but not 

necessary.

• Experience: 3-5 years Data Management experience in a GLP environment.

• An equivalent combination of education and experience may be accepted as a satisfactory 

substitute for the specific education and experience listed above.

• Certification/Licensure: None

• Other: Must be proficient in moderately complex table preparation and performing statistical 

analyses. Able to perform all database edits and input and edit computer protocols with no 

assistance. Proficient in the use of the SAS System, Microsoft Excel, Microsoft Word and other 

programs strongly preferred.

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

 

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

 

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

 

For more information, please visit www.criver.com.

Nearest Major Market: Reno

Nearest Secondary Market: Tahoe

Job Segment: Research Scientist, Testing, Pharmaceutical, Data Management, Drafting, Science, Technology, Data, Engineering

Job posted: 2022-09-03

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