Datatrial provide software based solutions to the life science industry. Our EDC and eTMF products are used in the delivery of clinical trials globally. Our core solutions enable clinical organisations to better collaborate and safely capture, store, and analyse their trial data and information.
We are looking for someone who:
• Has experience in quality and compliance management for Clinical Trials (+3 years).
• Has experience of GxP systems.
• Has knowledge of regulations surrounding the creation of software within the industry (21 CFR Part 11, EU Annex 11).
• Is able to both conduct and support audit activities for our vendors, as well as on our suppliers.
• Can support employees in maintaining and complying with organisation SOPs and Training.
• Has knowledge of CAPA and can put this into action to resolve any findings from audits.
• Preferably has prior knowledge of GAMP5 and its role within software development in clinical trials.
We can offer:
• A role that allows you to put your own mark on quality standards at the organisation.
• A great team of committed individuals to help support your work.
• Variety in the role. Our projects differ in size and require different levels of quality oversight. We offer exposure to modern development practices and systems.
The role can be remote or office based, or a mix of the two. You will be responsible growing and improving the quality system at Datatrial, which is currently used to support our development and delivery activities. You will work closely with the software development and delivery teams to ensure work conducted follows the processes you define, to ultimately ensure we are continuing to deliver compliant and robust technology to our partners.
• Thorough knowledge of GCP and regulatory requirements.
• Prior experience in a life science quality role.
• Prior audit experience (both auditing and being audited).
• Strong written and verbal communication skills.
• Prior exposure to quality processes around software development within clinical trials.
• A pragmatic approach to quality and its implementation.
• Responsive to customer requirements and the ability to fit quality into customer projects.