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Trial Data Manager

Website Achieva Group Limited

An excellent opportunity has arisen to join a leading pharmaceutical company as a Clinical Data Manager.

Requirments

• Ensures that Data Management (Biometry) activities (related to assigned study)adhere to Idorsia Standards, and applicable regulations
• Meets study timelines in terms of Data Management deliverables
• Ensures data handling consistency within allocated study(ies)
• Leads Data Management activities for assigned study
• Provides Data Management input to the development of the study protocol
• Coordinates the development of the (e)CRF in line with Idorsia standards
• Writes all study Data Management documents covering specifications forexternal data transfer, data cleanings and review tools that will be furtherprovided to Data Management Programmer(s) for development for the allocatedstudy(ies)

Candidate’s Experience

• Recognized degree in life sciences, mathematics, statistics, informatics or related disciplines
• At least 3 years’ experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical Data Management with good level of functional expertise in Data Management
• Good knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization – Good Clinical Practice (ICH/GCP))
• Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) design
• Ability to lead and coordinate the activity of Data Manager(s) allocated to his/her study
• Good organizational and presentation skills
• Fluent in written and spoken English

For further details, please contact Mark Cussens on +44 1727 817623 or email a copy of your CV to mcussens@achieva.co.uk

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