To provide management and leadership of the Clinical Database Programming team; ensuring the efficient, accurate and timely management of Clinical Database Programming deliverables.
Responsibilities
- Proactively manage and develop the performance of Clinical Database Programmers through performance management, capability, training and development to meet the needs of the business.
- To liaise with relevant staff to determine the allocation of tasks, to establish timelines, to report progress and any issues outstanding.
- To assist with assessing the technical merits and development of, and changes to, software applications and databases (both internal and 3rd party).
- To manage EDC development work allocated to the Clinical Database Programmers in order to achieve timely delivery.
- 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.
- 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.
- Develop and maintain database libraries in assigned applications.
- Be involved in ongoing planning, progress reporting, monitoring of systems and study metrics.
- Be involved in the development and technical leadership of current processes and implementation of new solutions.
- To support Data Management in the production and maintenance of system procedures and documentation in accord