Program and Application Development

Your Role:

• Develop, validate, document, and maintain program(s) and applications required to conduct or support clinical data quality checking and surveillance for clinical trials and/or programs, (e.g DQSP, CQR, coding checks, SQSP, SDTM checker, SAE/external data reconciliation, required reports, listings or figures with SAS, R or other programming languages)

• Create, validate, document, and maintain data conversion programs, follow company level standard.

• Run (the developed) tools, programs and macros according to timelines communicated by the ordering client/role

• Ad hoc programming requests (e.g data format transfer and data pooling per request)

General

• Contribute to the continuous improvement, re-engineering and implementation of processes, tools, technologies, conventions, standards, policies, Standard Operating Procedures (SOPs), and Working Instructions (WIs) as needed

• Works effectively in a mixed environment and uses best practices and knowledge to improve products or services and to define processes and standards.

• Solves moderate complexity problems based on advanced to sophisticated analytical skills and complex judgement.

• Accountable for the quality of on-going activities/processes. Receives minimal guidance or works independently.

• Contribute as team member to DMMI initiatives

• Develop experience and skills in new systems when necessary

• Keep up to date with job related topics, in particular with regard to SAS, R and Spotfire and other potential language and applications

Database Development:

• Develop and maintain standard libraries including e-CRFs, edit checks and programs within EDC and other relevant DMMI systems.

• Deliver high quality and timely database design deliverables and ensure the database readiness

• Conduct system validation as needed

• Mentor other DBDs in all aspects of DMMI process, as needed

• Assume the role of EDC Specialist/EDC Lead User if required

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