Clinical Data Management Manager

3 weeks ago

United Kingdom Allergy Therapeutics Full time

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.

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.

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
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
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.

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