About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first product for Non-Small Cell Lung Cancer expected to enter the clinic in 2H 2019.
An excellent opportunity has arisen for an eTMF Specialist, responsible for implementing, owning and managing the eTMF (Electronic Trial Master File) system. We are looking to have the successful candidate in position by the end of 2019.
• Work with a selected vendor to set up, implement and maintain an eTMF (Trial Master File);
• Work with third party vendors to ensure that the eTMF platform and electronic data platform is able to be used at scale and fully integrated to meet the business needs.
• Manage and run the eTMF in accordance with the DIA reference model and be responsible for the oversight of compliance alongside quality functions and data privacy requirements
• Collect, coordinate and maintain essential documents and ensures the completeness of the Trial Master File (TMF) for assigned clinical studies
• Propose quality standards and oversee compliance;
• Respond to problems and assist in implementing corrective and preventive actions;
• Support the ongoing use of the CTMS
• Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files.
• Contribute towards building new internal processes and systems within the clinical operations team to support the company’s growth
• Ensure inspection readiness
Education and Qualifications:
Bachelor’s degree or equivalent in life sciences or allied health fields such as nursing, pharmacy or health science.
Skills, Experience and Personal Attributes:
• Experience of either leading or involvement in the implementation of an eTMF system
• Experience of initiating, managing, running and maintaining an eTMF system
• Relevant clinical research experience in industry or in clinical practice as a trial/study coordinator
• Good understanding of GDPR and data privacy requirements
• Experience of working with patient tracking systems, financial tracking systems, archive document systems,
• Good understanding of how internal IT systems interface with external vendor systems
• Experience of working with current ICH/GCP guidelines
• Highly PC literate; able to learn and get up to speed with new IT systems as needed
• Good planning and organisational skills with strong attention to detail
• Good verbal and written communication skills
• Excellent team player
• Highly self-motivated with a “can do” attitude
• Positive and enthusiastic approach to work
• Flexible and able to respond to changing work priorities and mutli tasking
• Embraces change and happy to work in a growing and changing organisation
This is a permanent position, based in Stevenage with a competitive salary and benefits package.
Please send your CV with a covering letter by clicking Apply.