Senior Data Manager
Posted on Mar 17, 2019 by AL2S3 LTD
Provide data management input to relevant strategic study documents (e.g. study protocol) and vendor contracts.
Create or ensure development of relevant Data Management documentation (i.e. Data Management Plan).
Ensure high quality data management support for projects through the evaluation of CRO suppliers, and provide input into outsourcing strategy and processes.
Validate or review study data in CDISC format using available tools according to client standards
Coordinate data deliverables and adherence to relevant government guidelines in preparation for submission.
Ensure new data system(s) and new technical tools/equipment(s) to be used are in compliance by following the established guidelines of national and international regulatory authorities.
Work as a member of the Clinical Team to establish, communicate and deliver on a clinical data handling strategy and plan.
University degree in Life/Health Science,/Computer Science or equivalent.
Experience of regulatory submission in CDISC format.
Excellent skills in writing Data Management specific documents (e.g.Reviewers Guide, User Requirement Specification and Data Management Plans).
Extensive knowledge in CDISC data standards and controlled terminology
Familiar with common external coding dictionaries (e.g. MedDRA, WHO DD).
Previous experience performing CRO oversight activities.
This position is available to start from the beginning of May. For more information, please apply.