Clinical Data ReviewerManager
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Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
For 75years 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 return well help you build a career that you can feel passionate about.
Job Summary
Are you an experienced Clinical Data Reviewer
Do you enjoy working directly with clients and building strong working relationships
Charles River Laboratories are looking to recruit for a Clinical Data Manager/Clinical Data Reviewer on a full time permanent basis. Working remotely (within the UK or EU) this role combines expertise in clinical data management and clinical data review ensuring accurate timely and compliant reporting of complex clinical trial data across multiple projects.
You will play a critical role in maintaining data integrity supporting regulatory compliance and driving process improvements within our global safety assessment operations.
What youll be doing:
Data Management & Transfer
o Oversee preparation and review of Data Transfer Agreements for all assay data types.
o Present data to and liaise with clients regularly building and fostering strong working relationships with key stakeholders.
o Manage creation and quality control of Study Data Tabulation Model (SDTM) and non-SDTM datasets.
o Ensure datasets are prepared and transferred to sponsors in compliance with applicable regulations.
o Utilize acceptable data exchange platforms for secure dataset transfers.
Data Review & Quality Control
o Review clinical trial data for completeness accuracy and adherence to protocol and standards.
o Verify data coding integrity and reliability of collection and interpretation.
o Perform quality control checks on all aspects of clinical studies including regulatory compliance and documentation.
Collaboration & Leadership
o Coordinate with internal teams and external clients throughout the clinical data lifecycle.
o Mentor and train peers and junior staff; function as team lead when required (at Manager level)
o Host and attend internal/external meetings to ensure alignment on strategy and timelines.
Process Improvement
o Develop and maintain data templates tools and SOPs.
o Lead or support initiatives for process improvement and automation within data management and QC teams (At Manager level)
Profile and Requirements
Education: Bachelors degree in a scientific discipline preferred.
Experience:
o Significant track record in a research or pharmaceutical environment with strong data management experience.
o Demonstrable hands-on experience in clinical data review; CRO/Pharma experience preferred.
o Proven experience in customer facing roles within clinical data space able to develop and maintain relationships with stakeholders (internal and external).
Technical Skills:
o Knowledge of CDISC standards (CDASH SDTM Controlled Terminology).
o Familiarity with data output formats (.xml .xpt sas7bdat ASCII text .DAT .xlsx).
o Proficiency in Microsoft Office Suite; ability to learn validated systems.
Soft Skills:
o Excellent organizational communication and leadership skills.
o Ability to manage complex workloads under tight timelines.
o At the Manager level we are looking for exceptional customer service skills able to build and maintain strong working relationships with internal and external stakeholders.
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 20000 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 clients 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 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 80% of the drugs approved by the FDA in the last five years.
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.
Required Experience:
Manager
Key Skills
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About Company
Find your moment to make a significant impact on global health with a career at Charles River
