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Job Description
- Req#: 227516
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 Summary
BASIC SUMMARY: Coordinate and lead post-analysis study data activities to promote quality and timely completion of the data life cycle in accordance to all applicable regulatory and facility policy or practice.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Serve as data lead on assigned analytical team or studies to assure data quality in compliance with Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs) Standard Operating Procedures (SOPs), study protocols or Sponsor guidance documents and company policies/practices.
•Coordinate with applicable department personnel to ensure raw data/results move through the data life cycle as expected.
•Maintain accountability to the timely completion of critical data flow milestones in support of laboratory schedules and study timelines.
•Proficient in all data collection, review, and correction skills, and work flows of the Data Assistant role.
•Perform quality control review on raw data and results tables of any complexity, including the use of quality control check tools, to ensure data accuracy.
•Maintain data protection and organization in appropriate study binder preparations, storage, and filing.
•Read study protocols, analytical procedures, or Sponsor guidance documents to extract pertinent information related to data requirements, content, and/or format.
•Perform database/spreadsheet entry or maintenance for various department metrics or data tracking reasons.
•Tabulate study data of complex studies to create an accurate representation of data as indicated by study protocols.
•Prepare data (all mediums) for archival and/or shipment to Sponsor.
•Assist Data Coordinator II with study data or data project activities.
•Assist in preparing responses to both internal and external quality assurance audits.
•May specialize in discipline specific data management projects or workflows.
•Serve as a model as it relates to effective time management, communication and utilization of resources, and safety in the laboratory.
•Perform all other related duties as assigned.Job Qualifications
• Education: High school diploma or General Education Degree (G.E.D.) required. Associate’s (A.A./A.S.) degree or higher in a life sciences field preferred.
The pay range for this position starts at $28.00/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
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.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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.
About the company
Charles River Laboratories, Inc., is an American corporation specializing in a variety of preclinical and clinical laboratory services for the pharmaceutical, medical device and biotechnology industries.