Candidates

Data Manager

When a clinical trial takes place the data that is gathered about this is extremely important. This data will be analysed to show whether or not the drug is actually working.

Working within data management could mean that you hold a variety of roles and work with a range of people including Programming, Data co-ordination, CRF design, Statistics and Electronic Data Capture specialists.

A Data manager is responsible for the cleaning of clinical trials data in line with ICH GCP (Good Clinical Practice). Using databases like Oracle Clinical and ClinTrial they will manage and track the data flow form the beginning and end of a trial liaising with other departments to ensure that the data is being effectively and efficiently collected.

Attention to detail, excellent communication and liaison skills, ability to manage peoples expectations and an excellent understanding of the clinical trial process will all help to make you a good data manager.

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Job of the week - Senior Contract Regulatory Professional

Our client is a leading Pharmaceutical company. This R&D group have a large and dynamic European Regulatory Affairs Department responsible for the regulatory affairs work for the CNS R&D in Europe, Turkey, CEE region, Israel, South Africa, New Zealand and Australia.

The work has several aspects;

  • Communication to the Global Regulatory Teams and the supporting functions for regulatory submissions, such as clinical;
  • Working with the local operating companies within the^allocated region and external communication to regulatory authorities in the regions and to the EMEA. The group covers both developmental compounds not yet licensed and the maintenance and further development of marketed products. The prime responsibility for compounds is with the European Regulatory Liaison (EURL) who is responsible for the regulatory activities in the region and inputs to the global regulatory aspects for the compound.Regulatory consultants will work for an EURL or a global regulatory leader in the CNS therapeutic area or in the mature products area. They will work on the practical aspects of the compounds assigned from clinical trial applications (CTA’s), ASR’s, requests for scientific advice, MAA preparation, variations, renewals, PSURs etc depending on the life cycle of the compounds assigned. They may work on one or several compounds depending upon the work required for any compound at the time. Their work will be assigned and monitored by the EURL or theglobal regulatory lead responsible for the consultant.Eligibility to work in the EEA is required