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, well help you build a career that you can feel passionate about.
Responsible for acquisition of study data from multiple data sources and process data through specialized software. Perform quality control review with great attention to detail on the resulting SEND dataset to ensure data accuracy.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Create SEND datasets for electronic submissions per client request.
- Understand industry documents such as the study plan/protocol, study schedules, deviations, drafts and final reports in order to compare them with the electronic data and ensure the data is accurate.
- Manage standardized glossaries and co-ordinate with all other collection system glossaries administrators.
- Ensure work is compliant with applicable guidelines and regulations (e.g., CDISC SEND IG, SOP, GLP, PLC, MVP, etc.).
- Perform review and appraisals of computer software and associated products for electronic submissions.
- Assist in defining and delivering project and change control deliverables.
- Provide training and support as required.
- Provide support to users for data capture for electronic submission compliance.
- Assist with global system process change for electronic submissions compliance.
- Consistently deliver high-quality services to customers and manage customer expectations effectively.
- Communicate effectively with business to identify needs and evaluate alternative business solutions with project management.
- Perform all other related duties as assigned.
- Education: Bachelors degree (B.A./B.S.) or equivalent in a scientific or related discipline
- Experience: One to two years related experience in a scientific 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: 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. Ability to adhere to timelines.
- Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
- Must occasionally move about inside the office to access file cabinets, office machinery, etc.
- Regularly provides information to and receives information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange information in these situations.
General office working conditions; the noise level is usually moderate.
About Corporate Functions
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
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 clients 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 peoples 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.
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Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet
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