- Design and validation of CRDs/e-CRDs, as well as the programming of edit checks and data listings according to the required protocols and specifications.

- Develop specifications and procedures for data transfer to SAS according to the needs of statistical analysis. Collaborate with statisticians in data analysis.

- Develop Data Management Plan (DMP) for clinical trials.

- Document all programming and procedures to ensure accurate historical tracking of all data management activities in a clinical trial.

- Clinical data processing, including CRD data review, query generation and resolution, data review, medical coding and quality control procedures.

- Prepare reports on the status of clinical trial data.

- DB closure tasks and all activities related to final data cleansing including contacting sites to resolve outstanding queries.

- Development of standard operating procedures (SOPs) for the standardisation of data management processes in clinical trials.

- Be familiar with the applicable clinical trial and data quality regulations and any other applicable regulations.