Senior IT Analyst, Electronic Submissions - United States
For nearly 70 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.Business Summary
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 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.
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 ~70% of the drugs approved by the FDA in 2016.
For more information, please visit www.criver.com.Responsibilities
We are seeking an experienced SEND Analyst for our Information Technology site located in Wilmington
SEND is a new standard mandated by the FDA. This standard requires the pharmaceutical industry to submit their data in a predetermined electronic format. Charles River has been an active participant in designing this standard and is now a market leader in its compliance. In this role, you will be responsible for the acquisition of study data from multiple data sources, including laboratory information management systems, processing the data through specialized software, and performing a quality control review on the resulting SEND dataset to ensure the data are equivalent to that presented in the study report.
This is a chance to be at the forefront of industry needs and gain new and highly valued skills. We want you to become part of an “A” team that makes better science possible, to create better medicine, to create a better world.
The following are minimum requirements related to the Senior IT Analyst, Electronic Submissions position.
- Bachelor’s degree (B.A./B.S.) or equivalent in a scientific or related discipline and 4 years of related experience. (An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.)
- Experience in one or more of the following pharmaceutical industry disciplines is required: SEND, Reporting, Quality Assurance, Data coordination/acquisition/review
- This position requires analytical thinking skills and a good understanding of scientific data, as well as a general understanding of CDISC Standards.
- Proficiency with MS Excel required.
- Requires excellent communication and interpersonal skills.
- Requires great attention to detail.
- Ability to work well in a team environment.
- Knowledge of the Provantis system is a plus.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet