Clinical Data Manager
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What you'll do
- 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.
What they're looking for
- 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.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 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.
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.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to fostering a sense of belonging and work daily in this direction.
Company
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