Create, implement and execute procedures to build and maintain database set-up for paper based and / or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.
Create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.
Accountable for first time quality on all deliverables.
Provide feedback for study programmers on the creation of eCRF’sfollowing SOPs and internal process guidelines.
Assist in providing technical solutions to internal or external client
Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting and other programming language usage and processes within the GDO area.
Maintain all supporting documentation for studies in accordance with SOPs / Guidelines / Work Instructions to ensure traceability and regulatory compliance.
This includes the documentation of any deviations and dissemination of these to the rest of the project teams.
Maintain technical documentation that is applicable to the Clinical Database.
CRO or Pharm experience.
Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
Attention to detail.