Senior Clinical Data Architect
4 weeks ago
At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.
Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.
As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.
Our Department of Chromatographic Bioanalysis here in Edinburgh uses advanced hyphenated chromatography techniques within a world class facility to support the quantitative analysis of drug candidates in discovery and development. Several opportunities exist for Industrial Placement candidates to develop their laboratory skills while contributing to the development of Human therapies.
Profile and Requirements- Experience in programming with data science focused language eg SAS, SDTM
- Experience in handling/processing large and complex datasets
- Experience in compiling data transfer agreements
- To be aware, understand and comply with all applicable standard procedures, Regulatory and Legal requirements (ICH-GCP, Statutory Instruments and SOPs) requirements.
- Own the development and implementation of data management procedures tailored to ensure that optimal use is made of the clinical data management systems and standards are met. This will include the development and drafting of Standard Operation Procedures and including the training of staff.
- Engage with Client data management functions to ensure effective start up and execution of data transfer procedures.
- Review and contribute to commercial activities
- Review and contribute to Client facing documentation such as statements of work or contracts
- Deliver Quality Checked test files to Clients
- Maintain compliance with Charles River Laboratories quality management systems
- Collaborate with Clients in-study on modifications and bespoke requests
- Facilitate data management processes at data lock
- Represent Charles River in Client visits, audits, monitoring authority inspections
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 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 86% of the drugs approved by the FDA in 2021.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.
For more information, please visit www.criver.com.
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