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Senior Study Analyst Ashland United States,  

Charles River (company)

Posted on : 24 May 2017

Project Description

  • We are seeking an experienced Senior Study Analyst for our Safety Assessment site.
  • Responsible for monitoring of study progress from initiation to completion, production of interim reports/data tables, and generation of end-of-study reports for assigned studies in accordance with Good Laboratory Practice Regulations and WIL Standard Operating Procedures with little or no supervision/instruction. 
  • Responsibilities include review of study records and preparation of methodology section of reports, collation and quality control of data, preparation of report tables, scientific interpretation of data and writing the results of the study for submission to study director, client and governmental regulatory agencies. 
  •  Fulfills a leadership role within the department for less-experienced analysts, including assisting in the training of other personnel.

The following are minimum requirements related to the Senior Study Analyst position.
  •   All functions of Study Analyst
  •   Ability to generate study reports with minimal departmental oversight/review
  •   Assist with development of new techniques and software validation
  •   Assist with review of reports and design of new report formats
  •   Training of personnel
  •   Computer protocol editing
  •   Analyze and improve processes
  •   Assist technical advisers, supervisors and managers
  •   Proficient in generating all types of reports in at least one major area and knowledgeable in others
  •   Act as primary point of contact for assigned projects and/or processes/procedures

About Safety Assessment
  • Our company  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 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Us:
  • For nearly 70 years, our 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.
  • Our company 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. 
  • Our company 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 11,000 employees within 70 facilities in 18 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. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015. 
  • 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 ~70% of the drugs approved by the FDA in 2016.

Equal Employment Opportunity
Our company is an Equal Opportunity Employer M/F/Disabled/Vet


Ashland Ohio

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