Data Manager

•      i.        Develop Standard Operating Procedures (SOP), Data Management Plans (DMP), Data Quality Plans for the ITARA study

•    ii.        Ensure that these and other study plans as delegated/required are followed throughout the life time of the ITARA study, according to the study protocol and in keeping with study requirements.

•   iii.        Participate in the design and set up of the study database, in collaboration with the ITARA study team and data management team

•   iv.        Ensure that the study database, external data files and analysis datasets are developed in keeping with the SOPs and DMP, and maintained in a standard, accurate, complete, and consistent format conducive to analysis and regulatory submission.

•     v.        Participate in the design and set up of study case record forms (CRFs) using an electronic data capture system (E.g. RedCAP), in collaboration with the ITARA study team and data management team

•   vi.        Train local research staff in the use of electronic data capture systems (E.g. RedCAP) and in data collection and study SOPs as required. This includes creation of training documentation and running training sessions for end users.

• vii.        Maintain and update study laptops/tablets and other equipment used for data collection, ensuring data is downloaded daily/promptly and that forms are updated as needed.

• viii.        Coordinate data collection, back up, and storage of data in keeping with the DMP and SOPs, including ensuring that all study data are uploaded promptly and completely.

•      ix.          To liase regularly with the ITARA data management leads, the study team and study partners/collaborators through in person / online meetings, as required.

•    x.        To draft interim reports to the Principal Investigators, Sponsor, regulatory authorities, and oversight committees as requested by the ITARA site leads and PIs