Team Lead Data Coordination
Charles River Laboratories International Inc (CRL)
Ashland, OH, US, 44805
Team Lead Data Coordination Req ID #: 179387 Location:
Ashland, OH, US, 44805 For 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. Job Summary We are seeking a Team Lead Data Coordinator for our Safety Assessment group site located in Ashland, Ohio.
Assist department management with oversight and daily supervision of data coordination (DC) personnel. Tabulate data and statistics on any type of study (i.e., standard tox, DART). Provide protocol and report support to study directors, and assist with providing information/data requested by Sponsors. Provide leadership, reporting guidance, and serve as a mentor to less experienced staff.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Attend pre-study meetings and monitor events during the in-life phase to assure a full understanding of assigned projects and results, including objectives, timelines and reporting requirements.
• Assist Study Director and department management in monitoring progress of assigned studies.
• Prepare requested update tables and/or figures for Sponsors.
• Primary review of report tables, figures, and data export files.
• Collation and quality control of data and report pieces.
• Preparation, verification, and proofreading of report tables.
• Routine print-editing and post-processing of report tables.
• Running statistical analysis programs.
• Generation of manual report tables, Common Technical Documents (CTD), and any other regulatory agency summary table requirement (as needed).
• Maintaining active record of data table and report transfers during generation and review.
• Collaboration with other appropriate company personnel as needed.
• Maintain training materials and guidance documents.
• Train new employees.
• Other duties as assigned by departmental management. Job Qualifications
• Education: BA/BS degree in natural sciences field (preferred) or AS degree in a natural sciences/technical writing/computer sciences field with appropriate experience (2-3 years preferred).
• Experience: At least 1 year experience in a GLP laboratory environment preferred. 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: Proficient with Microsoft Office® (e.g., Word, Excel, Outlook), Adobe Acrobat PDF software, and appropriate publishing software. Key skills include attention to detail, personal computer literacy, a good understanding of scientific procedures and excellent interpersonal, and organizational skills. Ability to interact effectively with diverse personalities and ethnic backgrounds is essential. Completed training in use of Provantis, Nevis, WTDMSTM (including print-editing). Knowledge of GLP regulations.
Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19. Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition ([email protected]) so that information can be provided about the accommodation process at Charles River.
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 120 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 18,000 employees within 100 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 >80% of the drugs approved by the FDA for the past 3 years.
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 [email protected] 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: Cleveland
Nearest Secondary Market: Mansfield
Job Segment: Manager, Pharmaceutical, Statistics, Recruiting, Laboratory, Management, Data, Science, Human Resources
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