Job Overview

Do you have expertise in and a passion for Clinical Data Management?

Have you got the desire to improve health and lives?

Charles River Laboratories are excited to be recruiting for a Clinical Data Manager as part of our Clinical Support Services function, working remotely (within the UK only) to effectively manage varying levels of complex clinical trial data across multiple assigned projects within Safety Assessment. 

As Clinical Data Manager, you’ll be ensuring that all data is reported accurately and within the set timelines as per the driving documents and standards. You will be utilise a deep understanding of working to CDISC SDTM data standards, coupled with being able to demonstrate outstanding customer service skills to coordinate Safety Assessment site operations and clients throughout the clinical data life cycle. 

Job Description

What you’ll be doing:

•    Request requirements from the sponsor for transfer frequency and dataset architecture for data transferred to sponsors in support of clinical study work. 
•    Prepare and/or review Data Transfer Agreements for all assay data types of any complexity. 
•    Oversee preparation of the Study Data Tabulation Model (SDTM) and non-SDTM datasets for a clinical study. 
•    Perform quality control on all aspects of the clinical study as appropriate, to include, but not be limited to clinical regulatory compliance, Data Transfer Agreements, creation of clinical programming specifications, review of external client(s) clinical study documentation, review and management of data corrections via reconciliation requests from external client(s). 
•    Confirm clinical datasets are prepared and transferred to the sponsor in compliance with applicable regulations. 
•    Support peers in secondary document review and quality control activities for their assigned projects. 
•    Transfer datasets utilizing acceptable data exchange locations, such as internal or external data portal locations. 
•    Attend and/or host internal or external meetings as appropriate. 
•    Manage complex workload from assigned study projects with priority clients and expedited timelines. 
•    Mentor and train staff in support of business needs and team development. 
•    Develop, implement, and maintain data templates, tools. 
•    Draft and/or update relevant SOPs and other procedural documents. 
•    Able to function as team lead and support the Supervisor as needed with scheduling and other administrative activities. 
•    All other duties as assigned. 

Skills and Experience:

•    Bachelor’s degree within Life Sciences essential.  
•    Knowledge of CDISC’s CDASH, SDTM, and Controlled Terminology Standards. 
•    Significant experience of working within a similar clinical data management role, in other CRO or Pharmaceutical environments. 
•    Excellent communication skills and ability to work well with internal/external stakeholders
•    Familiarity with various data output formats (.xml, .xpt, sas7bdat, ASCII, text, .DAT, .xlsx). 
•    Knowledge of Microsoft Office Suite and ability to perform basic computer functions commensurate with the job responsibilities. 
•    Excellent organizational skills and the ability to meet deadlines. 
•    Excellent communication (both written and verbal), leadership and negotiation skills. 
•    Ability to interact appropriately with clients and all levels of employees, while at the same time support the efforts of departmental teams. 

All applicants must have full and permanent Right to Work in the UK as we are unable to provide sponsorship for this role. 

The salary for this role is up to £40,000/annum + bonus + benefits. Please note that the salary varies within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.