To co-ordinate and perform processes associated with the configuration, maintenance and validation of databases and database systems and associated applications.
Responsibilities
- To liaise with relevant staff to determine the allocation of tasks, to establish timelines, to report progress and any issues outstanding.
- To assist in training and mentoring Clinical Database Programmers in the configuration of databases and development, testing and running of SAS programs.
- To assist in training and mentoring Data Management staff in the specification of databases and SAS programs.
- To review specifications for the set-up and modification of project specific data entry software (including edit check specifications).
- Review validation plan for edit check and reconciliation check specifications.
- Develop, test and run SAS programs for clinical data management. This includes programs for data validation and reconciliation checks, data listings and data transfers.
- To configure database/eDC software (both internal and 3rd party) for the use of DM, sponsor and sites.
- To perform testing of databases and related applications according to IT and Data Management departmental SOPs, both for initial set-up and maintenance.
- To run database upload programs and to process any error reports.
- To liaise with 3rd party vendors to resolve issues, implement changes to software.
- To liaise with Sponsors or their designates on matters associated with the transfer of electronic data to or from the company, as defined by the Director, Data Management.
- To support Data Management in the production and maintenance of system procedures and documentation in accordance with applicable SOPs.
- Assist with Quality Assurance and Audit requirements.
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Other Skills and Abilities
- Be able to demonstr