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Clinical Data Manager

2 months ago

UK, UK, United Kingdom Allergy Therapeutics Full time

About Us

Allergy Therapeutics are a market leading, pioneering immunology business with specialist experience in the research and development of allergy treatments.


We believe that transformational outcomes for patients are achieved by directly treating the cause, rather than just managing symptoms. Our vaccines are aluminium free. Driving convenience; our ultra-short course treatments make life easier and increase adherence.


Our adjuvant technologies not only advance the results of allergy immunotherapy but also drive beneficial immune responses in cancer and infectious disease.


We are a proud and passionate team with a vision that delivers growth and transforms the way we think about immunology.


We are continuing to grow and it’s an exciting time to be joining us. You will contribute to our ongoing success and be part of our future which is looking very bright


You’ll join a team of like-minded people who are passionate about what they do and providing positive outcomes for our patients.


We are looking for a Clinical Data Manager to manage and coordinate all assigned internal or outsourced data management tasks, for Clinical R&D projects and other scientific research from initiation through to completion.


About you

We are looking for someone with proven experience in clinical data management processes within the pharma or biotechnology industry.


You will have a relevant degree in life sciences (or a related field) and any experience in allergy or respiratory areas would be beneficial although not essential.


Experience with Electronic Data Capture (EDC) systems, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug is important.


You will also have vendor management experience and knowledge of ICH, EMEA, MHRA and FDA guidance documents.


The role

You will be involved in the following:


Supporting Data Management function within Clinical Department

  • Support internal technical infrastructure of data management within ATL
  • Support in-house Study related Data Management activities
  • Support the development, review and implementation of departmental SOPs, templates and processes
  • Support budget and resource planning across assigned projects


Clinical Studies Planning

  • Participating in the design and Data Management scope of activities for new clinical studies within core programs of work
  • Reviewing project specific documentation for assigned trials, e.g. the Data Management Plan, Data Validation Specification and eCRF


Data Management Vendor Management and Oversight

  • Participating in CRO/vendor selection process for Data Management activities
  • Designing and communicating expectations and deliverables throughout the entire study
  • Overseeing execution of deliverables by CRO


Representing Data Management Function in Cross-functional R&D project teams

  • Manage data management timelines to coordinate and synchronize deliverables with the overall study timelines
  • Generate and/or reviews/approves study documents
  • Execute and/or distributes data management metrics, listings, and reports, as required.
  • Monitor the progress of all data management activities on assigned studies to ensure project timelines are met
  • Proactively identifies potential study issues/risks and recommend/implement solutions
  • Ensure accuracy and completeness of clinical data collected during a clinical trial


This is a remote role with a requirement to attend meetings on-site in Worthing as required.